ACURATE neo2™

Patient Information

Heart Valve

Jan 08, 2024

Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

Part Number 51213905-01A

ACURATE neo2™

Instructions for Use

Aortic Valve; Válvula aórtica; Valvule aortique; Válvula Aórtica Aortic Valve; Válvula aórtica; Valvule aortique; Válvula Aórtica

Jan 08, 2024

Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

Part Number 51081293-01A

Safety Related Revision Blank

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Dec 01, 2011

Product Code 2020

Part Number 102099-110

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

LATITUDE™

Integration Guides

LATITUDE™ Patient Management System

Mar 31, 2014

Product Code 6624

Part Number 350011-008

Applicable To INTEGRATION HL7 SPECIFICATION

RELIANCE™ 4-FRONT

Instructions for Use

Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation

Jul 14, 2022

Product Code 0654; 0682; 0683; 0655; 0685; 0686; 0650; 0662;0663;0651; 0636; 0665

Part Number 350063-081

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Programmer

Apr 22, 2022

Product Code 3300

Part Number 359488-058

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Implantable Cardioverter Defibrillator

Sep 01, 2014

Product Code A209

Part Number 359279-001

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Feb 01, 2017

Product Code 7740; 7741; 7742

Part Number 358659-059

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

Safety Related Revision No

VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Oct 06, 2014

Product Code U225; U226; U228; U125; U128; W274; W275; W272; W273; W172; W173

Part Number 359254-001

RESONATE™ EL ICD;VIGILANT™ EL ICD;ORIGEN™ MINI ICD;INOGEN™ EL ICD;ORIGEN™ EL ICD;AUTOGEN™ MINI ICD;PERCIVA™ HF ICD;CHARISMA™ EL ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ MINI ICD;RESONATE™ HF ICD;PERCIVA™ ICD;MOMENTUM™ EL ICD;AUTOGEN™ EL ICD

Patient Information

Implantable Cardioverter Defibrillator Therapy

Apr 29, 2011

Product Code N/A

Part Number 356394-023

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

May 01, 2018

Product Code 7731; 7732; 7735; 7736

Part Number 358661-040

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation; Pace/Sense Lead IS-1 Bipolar Connector Tined Fixation

Safety Related Revision No

DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;RESONATE™ HF CRT-D;ORIGEN™ CRT-D;RESONATE™ X4 CRT-D;AUTOGEN™ X4 CRT-D;MOMENTUM™ X4 CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ X4 CRT-D;RESONATE™ CRT-D;AUTOGEN™ CRT-D;CHARISMA™ CRT-D;MOMENTUM™ CRT-D;CHARISMA™ X4 CRT-D

Patient Information

Cardiac Resynchronization Therapy Defibrillator

Apr 29, 2011

Product Code

Part Number 356874-023

LATITUDE™ Programming System;LATITUDE™ Communicator;PERCIVA™ HF ICD;RESONATE™ HF ICD;RESONATE™ HF CRT-D;MOMENTUM™ EL ICD VR;MOMENTUM™ EL ICD DR;VIGILANT™ EL ICD;VIGILANT™ EL ICD;CHARISMA™ EL ICD VR;CHARISMA™ EL ICD DR;PERCIVA™ ICD VR;PERCIVA™ ICD DR;RESONATE™ EL ICD VR;RESONATE™ EL ICD DR;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D

Instructions for Use

Sep 01, 2016

Product Code 6290, D500, D501, D512, D513, D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548, D120, D121, D220, D221, D232, D233, D320, D321, D332, D333, D400, D401, D412, D413, D420, D421, D432, D433, G124, G125, G126, G128, G138, G224, G225, G228,G237 G247, G248, G324, G325, G328, G337, G347, G348, G424, G425, G426, G428, G437, G447, G448

Part Number 360206-001

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Electrode

Sep 01, 2015

Product Code 3401

Part Number 359469-001

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Network and Connectivity

Feb 01, 2018

Product Code 3300; 3924

Part Number 360166-020

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

Reference Guides

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Feb 01, 2015

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151 ; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

Part Number 359408-001

Safety Related Revision No

LATITUDE™

Clinician Manuals;Integration Guides

LATITUDE NXT Patient Management System

Aug 01, 2016

Product Code 6624; 6455

Part Number 359483-012

Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

Safety Related Revision No

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

Instructions for Use

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Feb 01, 2015

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151 ; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

Part Number 359404-001

Safety Related Revision No

INVIVE™;VALITUDE™;VALITUDE™ X4;INTUA™;VISIONIST™ X4;VISIONIST™

Patient Information

Cardiac Resynchronization Therapy

Feb 15, 2024

Product Code U225; U226; U228; U125; W272; W273; W172; W173; W274; W292

Part Number 356396-052

Safety Related Revision No

VALITUDE™;VISIONIST™ X4;INTUA™;INVIVE™;INLIVEN™;VALITUDE™ X4;VISIONIST™

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Jun 18, 2024

Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

Part Number 359244-033

Safety Related Revision Yes

PUNCTUA™ ICD;PUNCTUA™ NE ICD;ENERGEN™ ICD;INCEPTA™ ICD

Instructions for Use

IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

Nov 09, 2012

Product Code F050; F051; F052; F053; F140; F141; F142; F143; F160; F161; F162; F163

Part Number 358363-033

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

ACCOLADE™;FORMIO™;VITALIO™;INGENIO™;FORMIO™ MRI;ALTRUA™ 2;ADVANTIO™ MRI;INGENIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

Instructions for Use

Pacemaker

Jun 18, 2024

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J062; J063; J064; J065; J067

Part Number 359250-037

Safety Related Revision Yes

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

Reference Guides

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 01, 2017

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

Part Number 359408-033

Safety Related Revision No

PUNCTUA™ CRT-D;PUNCTUA™ NE CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code P052; P053

Part Number 358370-018

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Jul 07, 2021

Product Code A209; A219

Part Number 359481-055

Safety Related Revision No

ZOOM™ LATITUDE™

Programming Manuals

Programmer/Recorder/Monitor

Feb 28, 2014

Product Code 3120

Part Number 357435-130

RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

Reference Guides

Apr 01, 2017

Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

Part Number 360202-017

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Instrument til indføring af subkutan elektrode; Einführhilfe für subkutane Elektrode; Subcutaneous Electrode Insertion Tool; Outil d’insertion d’électrode sous-cutanée; Tunnellizzatore sottocutaneo; Subcutane elektrode insertie tool; Subkutant elektrodeinnføringsverktøy; Införingsverktyg för subkutan elektrod

Jun 02, 2014

Product Code 4711

Part Number 359316-001

VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Mar 01, 2018

Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

Part Number 359254-035

Safety Related Revision Yes

LATITUDE™ Programming System

Programming Manuals

Patient Data Management

Mar 01, 2017

Product Code 3300; 3931

Part Number 360194-001

Applicable To Application for use with the LATITUDE™ Programming System

ACCOLADE™;FORMIO™;VITALIO™;FORMIO™ MRI;INGENIO™;ALTRUA™ 2;ADVANTIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;INGENIO™ MRI;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

Reference Guides

PACEMAKER

Feb 15, 2024

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

Part Number 359241-033

Safety Related Revision Yes

EMBLEM™ S-ICD

Instructions for Use

Automated Screening Tool (AST)

Jan 13, 2021

Product Code 2889

Part Number 360195-001

Safety Related Revision No

ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;AUTOGEN™ X4 CRT-D;AUTOGEN™ EL ICD;DYNAGEN™ X4 CRT-D;DYNAGEN™ EL ICD;ENDOTAK RELIANCE™;FINELINE™ II;INGEVITY™ MRI;INOGEN™ EL ICD;INOGEN™ MINI ICD;INOGEN™ X4 CRT-D;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;ORIGEN™ X4 CRT-D;RELIANCE™ 4-FRONT;RESONATE™ CRT-D

MRI Information

Defibrillator

Aug 01, 2016

Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; G058; G148; G158; G179; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7735; 7736; 7740; 7741; 7742

Part Number 359447-038

Applicable To IMAGEREADY™

Safety Related Revision No

3300 LATITUDE™ Programming System

Programming Manuals

LATITUDE™ Programming System

Jul 31, 2023

Product Code 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331; 3154; 00802526586613; 6629; 00802526474071; 3889; 00802526613920

Part Number 92362142-027

Safety Related Revision No

ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight

Instructions for Use

Cardiac Lead

Jan 01, 2018

Product Code 4671; 4672; 4674; 4675; 4677; 4678

Part Number 92035847-019

Safety Related Revision No

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Nov 01, 2017

Product Code G172; G173;G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

Part Number 359402-036

Safety Related Revision No

DYNAGEN™ X4 CRT-D;VIGILANT™ EL ICD;INOGEN™ CRT-D;INGEVITY™ MRI;AUTOGEN™ MINI ICD;VIGILANT™ X4 CRT-D;CHARISMA™ EL ICD;ORIGEN™ CRT-D;INOGEN™ MINI ICD;AUTOGEN™ X4 CRT-D;RESONATE™ HF ICD;ACUITY™ Spiral;ENDOTAK RELIANCE™;AUTOGEN™ CRT-D;MOMENTUM™ EL ICD;DYNAGEN™ CRT-D;RESONATE™ EL ICD;ORIGEN™ MINI ICD;VIGILANT™ CRT-D;EASYTRAK™ 2;INOGEN™ EL ICD;ORIGEN™ EL ICD;RELIANCE™ 4-FRONT;ACUITY™ X4 Spiral L;PERCIVA™ HF ICD;RESONATE™ HF CRT-D;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;RESONATE™ X4 CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ACUITY™ X4 Spiral S;MOMENTUM™ X4 CRT-D;INOGEN™ X4 CRT-D;PERCIVA™ ICD;ORIGEN™ X4 CRT-D;RESONATE™ CRT-D;CHARISMA™ CRT-D;AUTOGEN™ EL ICD;MOMENTUM™ CRT-D;CHARISMA™ X4 CRT-D

MRI Information

Defibrillator

Nov 01, 2017

Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; D232; D233; D332; D333; D412; D413; D432; D433; D512; D513; D532; D533; G058; G148; G158; G179; G237; G247; G337;G347; G437; G447; G537; G547; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7148; 7735; 7736; 7740; 7741; 7742

Part Number 360205-019

Applicable To IMAGEREADY™

Safety Related Revision No

FINELINE™ II

Instructions for Use

Cardiac Lead

Mar 01, 2015

Product Code 4469; 4470; 4471; 4472; 4473; 4474

Part Number 355405-242

Applicable To FINELINE™ II STEROX EZ

Safety Related Revision No

VIGILANT™ CRT-D;CHARISMA™ CRT-D;RESONATE™ CRT-D;INOGEN™ CRT-D;MOMENTUM™ CRT-D;DYNAGEN™ CRT-D;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ X4 CRT-D;MOMENTUM™ X4 CRT-D;ORIGEN™ X4 CRT-D;AUTOGEN™ CRT-D;ORIGEN™ CRT-D;DYNAGEN™ X4 CRT-D;AUTOGEN™ X4 CRT-D

Patient Information

Cardiac Resynchronization Therapy Defibrillator

Oct 12, 2021

Product Code

Part Number 356874-040

Safety Related Revision No

RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

Reference Guides

Apr 01, 2017

Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

Part Number 360201-017

Safety Related Revision No

LATITUDE™

Clinician Manuals

LATITUDE NXT Patient Management System

Aug 01, 2018

Product Code 6446

Part Number 358827-063

Safety Related Revision No

LATITUDE™

Integration Guides

LATITUDE NXT Patient Management System

Feb 01, 2015

Product Code 6624

Part Number 359273-021

Applicable To LATITUDE INTEGRATION IDCO SPECIFICATION

Safety Related Revision No

LATITUDE™

Clinician Manuals

LATITUDE™ NXT Patient Management System

Oct 13, 2014

Product Code 6446;6448

Part Number 358827-010

LATITUDE™

Integration Guides

LATITUDE™ NXT Patient Management System

May 01, 2014

Product Code 6624

Part Number 359273-011

Applicable To LATITUDE INTEGRATION IDCO SPECIFICATION

Safety Related Revision No

LATITUDE™

Integration Guides

LATITUDE™ Patient Management System

Oct 13, 2013

Product Code 6624

Part Number 359273-001

Applicable To LATITUDE INTEGRATION IDCO SPECIFICATION

COGNIS™ 100-D CRT-D;TELIGEN™ 100

Instructions for Use;Supplemental Updates

Defibrillator

Jun 08, 2009

Product Code F102; F103; F110; F111; P106; P107; P108

Part Number 358201-001

Applicable To Important Software Update Information (v1.05)

EMBLEM™ S-ICD Programmer

Instructions for Use;Programming Manuals

EMBLEM™ S-ICD Programmer

Sep 14, 2022

Product Code 3200

Part Number 92346972-001

Safety Related Revision No

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

Instructions for Use

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 01, 2017

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

Part Number 359404-041

Safety Related Revision No

RELIANCE™ 4-FRONT

Instructions for Use

Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation

Mar 01, 2015

Product Code 0654; 0682; 0683; 0655; 0685; 0686; 0650; 0662;0663;0651; 0636; 0665

Part Number 350063-063

Safety Related Revision No

LATITUDE™ Communicator

Patient Information

LATITUDE™ Communicator

Mar 01, 2015

Product Code 6288; 6290

Part Number 359419-001

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

May 01, 2018

Product Code 7731; 7732; 7735; 7736

Part Number 358661-076

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

Safety Related Revision No

LATITUDE Link™

Integration Guides

LATITUDE Link™ System

Aug 01, 2014

Product Code 6215; 6216

Part Number 359384-001

Applicable To IDCO SPECIFICATION

LATITUDE™ Programming System

Programming Manuals

Network and Connectivity

Apr 22, 2022

Product Code 3300; 3924

Part Number 360166-039

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

VIGILANT™ EL ICD;INOGEN™ CRT-D;INGENIO™ MRI;INGENIO™;INVIVE™;VIGILANT™ X4 CRT-D;AUTOGEN™ MINI ICD;ORIGEN™ CRT-D;VISIONIST™ X4;ACCOLADE™ MRI;PROPONENT™ MRI;MOMENTUM™ EL ICD;ADVANTIO™;DYNAGEN™ CRT-D;RESONATE™ EL ICD;VIGILANT™ CRT-D;INOGEN™ EL ICD;ORIGEN™ EL ICD;RESONATE™ HF CRT-D;EQUIO™;VISIONIST™;MOMENTUM™ X4 CRT-D;ESSENTIO™;FORMIO™ MRI;FORMIO™;CHARISMA™ X4 CRT-D;VALITUDE™ X4;DYNAGEN™ X4 CRT-D;ACCOLADE™;ESSENTIO™ MRI;CHARISMA™ EL ICD;INOGEN™ MINI ICD;AUTOGEN™ X4 CRT-D;RESONATE™ HF ICD;ALTRUA™ 2;PROPONENT™;ADVANTIO™ MRI;INLIVEN™;AUTOGEN™ CRT-D;ORIGEN™ MINI ICD;VITALIO™;INTUA™;PERCIVA™ HF ICD;VITALIO™ MRI;RESONATE™ X4 CRT-D;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ X4 CRT-D;VALITUDE™;PERCIVA™ ICD;ORIGEN™ X4 CRT-D;RESONATE™ CRT-D;CHARISMA™ CRT-D;MOMENTUM™ CRT-D;AUTOGEN™ EL ICD

Miscellaneous

Defibrillator; Pacemaker

Dec 01, 2017

Product Code N/A

Part Number 357674-014

Applicable To Guide to Replacement of Cardiac Implantable Pulse Generators

Safety Related Revision No

EMBLEM™ S-ICD

Patient Information

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Jul 07, 2022

Product Code A209; A219; 3501

Part Number 92346920-001

Applicable To N/A

Applicable To N/A

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Programming Manuals

EMBLEM™ S-ICD Programmer

Sep 01, 2014

Product Code 3200

Part Number 359293-001

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Programming Manuals

EMBLEM™ S-ICD Programmer

Aug 01, 2017

Product Code 3200

Part Number 359465-033

Safety Related Revision No

PUNCTUA™ CRT-D;PUNCTUA™ NE CRT-D;ENERGEN™ CRT-D;INCEPTA™ CRT-D

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

Nov 09, 2012

Product Code P052; P053; P142; P143; P162; P163; P165

Part Number 358374-033

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subkutan elektrode; Subkutane Elektrode; Subcutaneous Electrode; Électrode sous-cutanée; Elettrodo sottocutaneo; Subcutane elektrode; Subkutan elektrode; Subkutan elektrod

Jun 01, 2014

Product Code 3401

Part Number 359315-001

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Nov 01, 2017

Product Code G172; G173;G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

Part Number 359406-035

Safety Related Revision No

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

Instructions for Use

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 01, 2017

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

Part Number 359404-037

Safety Related Revision No

RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

Instructions for Use

Apr 01, 2017

Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

Part Number 360204-019

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Feb 01, 2015

Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

Part Number 359406-001

Safety Related Revision No

ACCOLADE™;FORMIO™;VITALIO™;INGENIO™;FORMIO™ MRI;EQUIO™;ALTRUA™ 2;INLIVEN™;ADVANTIO™ MRI;INGENIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

Patient Information

Pacemaker Therapy

Jan 19, 2021

Product Code

Part Number 356395-027

COGNIS™ 100-D CRT-D

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

Oct 09, 2012

Product Code P106; P107; P108

Part Number 357485-094

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

VISIONIST™ X4;FORMIO™ MRI;ADVANTIO™ MRI;ACCOLADE™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;ACUITY™ X4 Spiral L;VITALIO™ MRI;ACUITY™ X4 Straight;FINELINE™ II;ACUITY™ X4 Spiral S;ESSENTIO™ MRI;VALITUDE™ X4

MRI Information

Pacemaker

Dec 21, 2021

Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; ;L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473;4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4676; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742

Part Number 359259-037

Applicable To IMAGEREADY™

Safety Related Revision Yes

LATITUDE™ Programming System

Programming Manuals

Programmer

Mar 01, 2017

Product Code 3300

Part Number 359488-001

FINELINE™ II

Instructions for Use

Cardiac Lead

Jun 21, 2022

Product Code 4469; 4470; 4471; 4472; 4473; 4474

Part Number 355405-242

Applicable To FINELINE™ II STEROX EZ

Safety Related Revision No

ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

Reference Guides

PACEMAKER

Oct 06, 2014

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J178; J175; J176; J177; J062; J063; J064; J065; J066; J067

Part Number 359241-001

LATITUDE™

Clinician Manuals

LATITUDE™ NXT Patient Management System

Mar 01, 2015

Product Code 6446; 6448

Part Number 358827-030

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Feb 01, 2017

Product Code 7731; 7732; 7735; 7736

Part Number 358661-058

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

Safety Related Revision No

CHARISMA™ EL ICD;CHARISMA™ CRT-D;FINELINE™ II Sterox;RESONATE™ CRT-D;RESONATE™ HF ICD;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;DYNAGEN™ CRT-D;MOMENTUM™ EL ICD;AUTOGEN™ EL ICD;RESONATE™ X4 CRT-D;RESONATE™ HF CRT-D;CHARISMA™ X4 CRT-D;INGEVITY™ MRI;MOMENTUM™ X4 CRT-D;ORIGEN™ MINI ICD;ORIGEN™ EL ICD;ENDOTAK RELIANCE™;VIGILANT™ EL ICD;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;EASYTRAK™ 2 IS-1;PERCIVA™ HF ICD;RELIANCE™ 4-FRONT;INOGEN™ CRT-D;FINELINE™ II Sterox EZ;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;DYNAGEN™ MINI ICD;RESONATE™ EL ICD;ACUITY™ X4 Spiral L;ORIGEN™ X4 CRT-D;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

MRI Information

IMAGEREADY™ MR Conditional Defibrillation System

Dec 05, 2022

Product Code D000; D001; D002; D003; D010; D011; D012; D013; D020; D021; D022; D023; D044; D045; D046; D047; D050; D051; D052; D053; D120; D121; D140; D141; D142; D143; D150; D151; D152; D153; D174; D175; D176; D177; D220; D221; D232; D233; D320; D321; D332; D333; D400; D401; D412; D413; D420; D421; D432; D433; D500; D501; D512; D513; D520; D521; D532; D533; G050; G051; G056; G058; G124; G125; G128; G138; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G177; G179; G224; G225; G228; G237; G247; G248; G324; G325; G328; G337; G347; G348; G424; G425; G428; G437; G447; G448; G524; G525; G528; G537; G547; G548; 0127; 0128; 0129; 0137; 0138; 0139; 0143; 0147; 0148; 0149; 0153; 0157; 0158; 0159; 0170; 0171; 0172; 0173; 0174; 0175; 0176; 0177; 0180; 0181; 0182; 0183; 0184; 0185; 0186; 0187; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4542; 4543; 4544; 4591; 4592; 4593; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6100; 6220; 6221; 6402; 6403; 6773; 6996; 7145; 7148; 7735; 7736; 7740; 7741; 7742

Part Number 51114107-001

Applicable To IMAGEREADY™

Safety Related Revision No

RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

Instructions for Use

Apr 01, 2017

Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

Part Number 360203-019

CHARISMA™ EL ICD;CHARISMA™ CRT-D;RESONATE™ HF ICD;RESONATE™ CRT-D;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;MOMENTUM™ EL ICD;DYNAGEN™ CRT-D;AUTOGEN™ EL ICD;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ X4 CRT-D;INGEVITY™ MRI;MOMENTUM™ X4 CRT-D;ORIGEN™ MINI ICD;ORIGEN™ EL ICD;VIGILANT™ EL ICD;ENDOTAK RELIANCE™;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;PERCIVA™ HF ICD;RELIANCE™ 4-FRONT;INOGEN™ CRT-D;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;RESONATE™ EL ICD;DYNAGEN™ MINI ICD;ACUITY™ X4 Spiral L;ORIGEN™ X4 CRT-D;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

MRI Information

Defibrillator

Oct 12, 2021

Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; D232; D233; D332; D333; D412; D413; D432; D433; D512; D513; D532; D533; G058; G148; G158; G179; G237; G247; G337;G347; G437; G447; G537; G547; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7148; 7735; 7736; 7740; 7741; 7742

Part Number 360205-037

Applicable To IMAGEREADY™

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Mar 02, 2015

Product Code 7731; 7732; 7735; 7736

Part Number 358661-040

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation; Pace/Sense Lead IS-1 Bipolar Connector Tined Fixation

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

May 01, 2018

Product Code 7740; 7741; 7742

Part Number 358659-113

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

Safety Related Revision No

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Feb 01, 2015

Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

Part Number 359402-001

Safety Related Revision No

CHARISMA™ EL ICD;CHARISMA™ CRT-D;RESONATE™ CRT-D;RESONATE™ HF ICD;FINELINE™ II Sterox;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;DYNAGEN™ CRT-D;MOMENTUM™ EL ICD;AUTOGEN™ EL ICD;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ X4 CRT-D;MOMENTUM™ X4 CRT-D;INGEVITY™ MRI;ORIGEN™ MINI ICD;ENDOTAK RELIANCE™ SG;ORIGEN™ EL ICD;VIGILANT™ EL ICD;ENDOTAK RELIANCE™;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;PERCIVA™ HF ICD;ENDOTAK RELIANCE™ S;EASYTRAK™ 2 IS-1;RELIANCE™ 4-FRONT;INGEVITY™+;INOGEN™ CRT-D;FINELINE™ II Sterox EZ;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;DYNAGEN™ MINI ICD;RESONATE™ EL ICD;ENDOTAK RELIANCE™ G;ORIGEN™ X4 CRT-D;ACUITY™ X4 Spiral L;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

MRI Information

IMAGEREADY™ MR Conditional Defibrillation System

Sep 12, 2022

Product Code D000; D001; D002; D003; D010; D011; D012; D013; D020; D021; D022; D023; D044; D045; D046; D047; D050; D051; D052; D053; D120; D121; D140; D141; D142; D143; D150; D151; D152; D153; D174; D175; D176; D177; D220; D221; D232; D233; D320; D321; D332; D333; D400; D401; D412; D413; D420; D421; D432; D433; D500; D501; D512; D513; D520; D521; D532; D533; G050; G051; G056; G058; G124; G125; G128; G138; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G177; G179; G224; G225; G228; G237; G247; G248; G324; G325; G328; G337; G347; G348; G424; G425; G428; G437; G447; G448; G524; G525; G528; G537; G547; G548; 0127; 0128; 0129; 0137; 0138; 0139; 0143; 0147; 0148; 0149; 0153; 0157; 0158; 0159; 0170; 0171; 0172; 0173; 0174; 0175; 0176; 0177; 0180; 0181; 0182; 0183; 0184; 0185; 0186; 0187; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4542; 4543; 4544; 4591; 4592; 4593; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6100; 6220; 6221; 6402; 6403; 6773; 6996; 7145; 7148; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

Part Number 51308710-001

Applicable To IMAGEREADY™

ENDOTAK RELIANCE™

Instructions for Use

Cardiac Lead

Mar 01, 2015

Product Code 0295; 0296; 0292; 0293; 0275; 0276

Part Number 358074-083

Applicable To Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation

Safety Related Revision No

INVIVE™;VALITUDE™;VALITUDE™ X4;INTUA™;VISIONIST™ X4;VISIONIST™

Patient Information

Cardiac Resynchronization Therapy

Jan 01, 2018

Product Code U225; U226; U228; U125; W272; W273; W172; W173; W274; W292

Part Number 356396-052

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Programming Manuals

EMBLEM™ S-ICD Programmer

Jul 07, 2021

Product Code 3200

Part Number 359465-065

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Electrode Insertion Tool

Sep 01, 2015

Product Code 4711

Part Number 359472-001

Safety Related Revision No

TELIGEN™ 100

Reference Guides

IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code F102; F103; F110; F111

Part Number 357403-075

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Electrode

Jul 07, 2021

Product Code 3501

Part Number 360168-019

Safety Related Revision No

EMBLEM™ S-ICD Electrode;Q-TRAK™ S-ICD Electrode;EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD;EMBLEM™ S-ICD Programmer

MRI Information

Subcutaneous Implantable Cardioverter Defibrillator; Subcutaneous Electrode

Jul 07, 2021

Product Code A209; A219; 3400; 3401; 3501

Part Number 359475-019

Applicable To IMAGEREADY™

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Network and Connectivity

Feb 01, 2017

Product Code 3300; 3924

Part Number 360166-001

Applicable To Application for use with the LATITUDE™ Programming System

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

Reference Guides

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 01, 2017

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

Part Number 359408-035

Safety Related Revision No

LATITUDE™ Communicator

Patient Information

LATITUDE™ Communicator

May 20, 2022

Product Code 6288; 6290

Part Number 359419-020

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Dec 01, 2014

Product Code 7731; 7732; 7735; 7736

Part Number 358661-022

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

Safety Related Revision No

INGEVITY™

Patient Information

Pace/Sense Lead

Feb 23, 2024

Product Code 7731; 7732; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

Part Number 50944538-028

Applicable To N/A

Applicable To N/A

ORIGEN™ MINI ICD;INOGEN™ MINI ICD;DYNAGEN™ MINI ICD VR;DYNAGEN™ MINI ICD DR;AUTOGEN™ MINI ICD VR;AUTOGEN™ MINI ICD DR;ORIGEN™ EL ICD;INOGEN™ EL ICD;INOGEN™ EL ICD;DYNAGEN™ EL ICD VR;DYNAGEN™ EL ICD DR;AUTOGEN™ EL ICD VR;AUTOGEN™ EL ICD DR;VIGILANT™ EL ICD;VIGILANT™ EL ICD;CHARISMA™ EL ICD VR;CHARISMA™ EL ICD DR;PERCIVA™ ICD VR;PERCIVA™ ICD DR;RESONATE™ EL ICD VR;RESONATE™ EL ICD DR;PERCIVA™ HF ICD;RESONATE™ HF ICD;ORIGEN™ X4 CRT-D;INOGEN™ X4 CRT-D;DYNAGEN™ X4 CRT-D;AUTOGEN™ X4 CRT-D;VIGILANT™ X4 CRT-D;CHARISMA™ X4 CRT-D;RESONATE™ X4 CRT-D;RESONATE™ HF CRT-D;ENDOTAK RELIANCE™;ENDOTAK RELIANCE™ S;ENDOTAK RELIANCE™ SG;ENDOTAK RELIANCE™ G;RELIANCE™ 4-FRONT;RELIANCE™ 4-FRONT;FINELINE™ II Sterox EZ;FINELINE™ II EZ Sterox;FINELINE™ II Sterox

MRI Information

IMAGEREADY™ MR CONDITIONAL DEFIBRILLATION SYSTEM

Aug 01, 2016

Product Code D000, D002, D010, D012, D020, D022, D044, D046, D050, D052, D140, D142, D150, D152, D174, D176, D232, D233, D332, D333, D412, D413, D432, D433, D512, D513, D532, D533, G058, G148, G158, G179, G237, G247, G337, G347, G437, G447, G537, G547, 0262, 0263, 0265, 0266, 0272, 0273, 0275, 0276, 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296, 0636, 0650, 0651, 0652, 0653, 0654, 0655, 0657, 0658, 0662, 0663, 0665, 0672, 0673, 0675, 0676, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696, 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480, 4603, 4671, 4672, 4674, 4675, 4677, 4678, 6220, 6221, 6402, 6403, 7145, 7148, 7735, 7736, 7740, 7741, 7742

Part Number 360205-001

ACCOLADE™;FORMIO™;VITALIO™;INGENIO™;FORMIO™ MRI;ALTRUA™ 2;ADVANTIO™ MRI;INGENIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

Reference Guides

PACEMAKER

Jun 18, 2024

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

Part Number 359241-033

Safety Related Revision Yes

3300 LATITUDE™ Programming System

Programming Manuals

Pacing System Analyzer (PSA)

Jul 31, 2023

Product Code 3922; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

Part Number 92402515-001

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Electrode Delivery System

Jul 07, 2021

Product Code 4712

Part Number 360210-001

ACUITY™ X4 Straight;ACUITY™ X4 Spiral S;ACUITY™ X4 Spiral L

Instructions for Use

Defibrillator

Jan 01, 2018

Product Code 4671, 4672, 4674, 4675, 4677, 4678

Part Number 92035847-001

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Apr 04, 2024

Product Code 7731; 7732; 7735; 7736

Part Number 358661-112

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

Safety Related Revision No

RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

Reference Guides

Sep 01, 2016

Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

Part Number 360202-001

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Electrode

Nov 01, 2016

Product Code 3501

Part Number 360168-001

VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Oct 06, 2014

Product Code U225; U226; U228; U125; U128; W274; W275; W272; W273; W172; W173

Part Number 359244-001

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

May 02, 2018

Product Code 7740; 7741; 7742

Part Number 358659-077

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Programming Manuals

EMBLEM™ S-ICD Programmer

Oct 01, 2018

Product Code 3200

Part Number 359465-049

Safety Related Revision No

LATITUDE™

Clinician Manuals

LATITUDE NXT Patient Management System

Oct 01, 2018

Product Code 6446; 6447

Part Number 358827-074

Safety Related Revision No

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Nov 17, 2013

Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058

Part Number 359209-001

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 01, 2016

Product Code A209; A219

Part Number 359481-019

Safety Related Revision No

LATITUDE™

Clinician Manuals

LATITUDE NXT Patient Management System

Jul 01, 2015

Product Code 6446

Part Number 358827-041

Safety Related Revision No

ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

Instructions for Use

Pacemaker

Mar 01, 2018

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J062; J063; J064; J065; J067

Part Number 359250-019

Safety Related Revision Yes

RELIANCE™ 4-FRONT

Instructions for Use

Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable Fixation

Mar 01, 2015

Product Code 0657; 0692; 0693; 0658; 0695; 0696; 0652; 0672; 0673; 0653; 0675; 0676

Part Number 350065-057

RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

Reference Guides

Sep 01, 2016

Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

Part Number 360201-001

EMBLEM™ S-ICD

Instructions for Use

Subcutaneous Electrode

Sep 14, 2022

Product Code 3501

Part Number 92346953-001

Applicable To N/A

Applicable To N/A

Safety Related Revision No

LATITUDE™ HEART CONNECT™

Operator's Manual;Programming Manuals;Instructions for Use

Heart Connect™ System

Aug 14, 2023

Product Code 3932; 3935; 3936; 3937; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

Part Number 92302087-001

VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Apr 01, 2018

Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

Part Number 359244-033

Safety Related Revision Yes

LATITUDE™ Communicator

Patient Information

LATITUDE™ Communicator

Apr 01, 2014

Product Code 6288; 6290

Part Number 359305-001

COGNIS™ 100-D CRT-D;TELIGEN™ 100

Instructions for Use;Supplemental Updates

Defibrillator

Oct 24, 2008

Product Code F102; F103; F110; F111; P106; P107; P108

Part Number 358009-001

Applicable To Important Software Update Information (v1.03)

EMBLEM™ S-ICD

Patient Information

EMBLEM™ S-ICD System

Jul 07, 2021

Product Code

Part Number 359285-037

Safety Related Revision No

RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

Instructions for Use

Sep 01, 2016

Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

Part Number 360204-001

LATITUDE Link™

Integration Guides

LATITUDE Link™ System

Aug 01, 2014

Product Code 6215; 6216

Part Number 359382-001

Applicable To HL7 SPECIFICATION

VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Mar 01, 2018

Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

Part Number 359254-018

Safety Related Revision Yes

ENDOTAK RELIANCE™

Instructions for Use

Cardiac Lead

Feb 01, 2016

Product Code 0285; 0286; 0282; 0283; 0265; 0266; 0262; 0263

Part Number 358079-096

Applicable To Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation; Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation; Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation; Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation

Safety Related Revision No

LATITUDE Link™

Instructions for Use;Programming Manuals

LATITUDE Link™ Data Management System

Sep 01, 2014

Product Code 6215; 6216

Part Number 359387-001

EMBLEM™ S-ICD

Patient Information

EMBLEM™ S-ICD System

Oct 01, 2014

Product Code N/A

Part Number 359285-001

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 01, 2015

Product Code A209; A219

Part Number 359481-001

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD;EMBLEM™ S-ICD Electrode;Q-TRAK™ S-ICD Electrode;EMBLEM™ S-ICD Programmer

MRI Information

Subcutaneous Implantable Cardioverter Defibrillator; Subcutaneous Electrode

Jan 01, 2019

Product Code A209; A219; 3400; 3401; 3501

Part Number 359475-001

Applicable To IMAGEREADY™

Safety Related Revision No

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Nov 01, 2017

Product Code G172; G173;G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

Part Number 359402-039

Safety Related Revision No

INVIVE™;VALITUDE™;VALITUDE™ X4;INTUA™;VISIONIST™ X4;VISIONIST™

Patient Information

Cardiac Resynchronization Therapy

Jan 01, 2018

Product Code U225; U226; U228; U125; W272; W273; W172; W173; W274; W292

Part Number 356396-035

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Pacing System Analyzer (PSA)

Jan 01, 2019

Product Code 3300; 3922

Part Number 360164-020

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Apr 02, 2018

Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

Part Number 359244-017

Safety Related Revision Yes

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Oct 01, 2013

Product Code 3200

Part Number 104749-003

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

INGEVITY™+

Instructions for Use

Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

Oct 27, 2023

Product Code 7840; 7841; 7842

Part Number 92383240-001

Applicable To N/A

Applicable To N/A

FINELINE™ II Sterox;VISIONIST™ X4;INGEVITY™+;FORMIO™ MRI;FINELINE™ II Sterox EZ;ADVANTIO™ MRI;ACCOLADE™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;ACUITY™ X4 Spiral L;VITALIO™ MRI;FINELINE™ II;ACUITY™ X4 Straight;ACUITY™ X4 Spiral S;VALITUDE™ X4;ESSENTIO™ MRI

MRI Information

IMAGEREADY™ MR Conditional Pacing System

Mar 23, 2023

Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

Part Number 359259-054

Applicable To IMAGEREADY™

Applicable To N/A

Safety Related Revision No

RELIANCE™ 4-FRONT

Instructions for Use

Cardiac Lead

Jun 11, 2012

Product Code 0657; 0658; 0675; 0676; 0692; 0693; 0695; 0696

Part Number 350065-019

Applicable To Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation

ENDOTAK RELIANCE™

Instructions for Use

Cardiac Lead

Feb 01, 2016

Product Code 0262; 0263; 0265; 0266; 0282; 0283; 0285; 0286

Part Number 358079-079

Applicable To Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Mar 02, 2015

Product Code 7740; 7741; 7742

Part Number 358659-041

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation; Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Oct 01, 2018

Product Code A209; A219

Part Number 359481-037

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Patient Data Management

Mar 01, 2017

Product Code 3300

Part Number 92059496-001

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Programming Manuals

S-ICD Programmer

Oct 01, 2015

Product Code 3200

Part Number 359465-001

Safety Related Revision No

LATITUDE™ Communicator

Supplemental Updates;Patient Information

Komunikátor LATITUDE™ ; LATITUDE™ Kommunikator ; LATITUDE™ Communicator ; Συσκευή επικοινωνίας LATITUDE™; LATITUDE™ Communicator; Comunicador LATITUDE™ ; Communicateur LATITUDE™ ; Comunicatore LATITUDE™ ; LATITUDE™ Communicator ; LATITUDE™ Kommunikator ; Komunikator LATITUDE™ ; Comunicador LATITUDE™; Komunikátor LATITUDE™ ; LATITUDE™ Kommunikator; LATITUDE™ Communicator; Communicateur LATITUDE™

May 20, 2022

Product Code 6545; 6288; 6290

Part Number 359426-001

Applicable To LATITUDE™ Communicator Patient Manual Supplement Hotspot Feature; Supplément au Manuel patient du Communicateur LATITUDE™ pour la fonction Hotspot; Dodatek k příručce pro pacienty ke komunikátoru LATITUDE™ k funkci Hotspot; Patienthåndbog til LATITUDE™-kommunicatoren – Supplement til Hotspot-funktion; LATITUDE™ Ergänzung zum Communicator- Patientenhandbuch für die Hotspot-Funktion; Συμπληρωματικό εγχειρίδιο Συσκευής επικοινωνίας LATITUDE™ για τον ασθενή - Λειτουργία Hotspot; LATITUDE™ Communicator Patient Manual Supplement Hotspot Feature; Apéndice del Manual del comunicador del paciente LATITUDE™: función de punto de acceso; Supplément au Manuel patient du Communicateur LATITUDE™ pour la fonction Hotspot; Supplemento al manuale per il paziente del Comunicatore LATITUDE™ relativo alla funzione hotspot; Aanvulling op de LATITUDE™ Communicator Patiëntenhandleiding voor de hotspotfunctie; Tillegg til pasienthåndbok for LATITUDE™-kommunikator – Hotspot-funksjonen; Suplement do Instrukcji obsługi komunikatora LATITUDE™ dla pacjenta dotyczący funkcji hotspot; Suplemento do Manual do Comunicador do Paciente LATITUDE™ para Funcionalidade Hotspot; Doplnok k manuálu komunikátora LATITUDE™ pre pacienta – funkcia Hotspot; Bilaga om hotspot-funktion till patienthandbok till LATITUDE™-kommunikator; LATITUDE™ Communicator Patient Manual Supplement Hotspot Feature

Safety Related Revision No

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

May 01, 2018

Product Code 7740; 7741; 7742

Part Number 358659-041

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation; Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

Safety Related Revision No

myLUX™;LUX-Dx™

Patient Information

myLUX™ Patient App for Insertable Cardiac Monitor

May 29, 2024

Product Code M301; 2925; 6259

Part Number 92216680-001

Safety Related Revision Blank

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

Dec 01, 2014

Product Code 7740; 7741; 7742

Part Number 358659-023

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Programmer

Jun 01, 2019

Product Code 3300

Part Number 359488-020

Safety Related Revision No

ENERGEN™ ICD

Reference Guides

IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code F140; F141; F142; F143

Part Number 358427-018

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

Reference Guides

PACEMAKER

Apr 01, 2018

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

Part Number 359241-017

Safety Related Revision Yes

PUNCTUA™ ICD;PUNCTUA™ NE ICD

Reference Guides

IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code F050; F051; F052; F053

Part Number 358359-018

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

LATITUDE™

Clinician Manuals;Integration Guides

LATITUDE NXT Patient Management System

Jul 01, 2022

Product Code 6624; 6455

Part Number 359483-012

Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

Safety Related Revision No

INCEPTA™ ICD

Reference Guides

IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code F160; F161; F162; F163

Part Number 358431-022

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Nov 17, 2013

Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058

Part Number 359059-019

LATITUDE™ Programming System

Programming Manuals

Patient Data Management

Apr 22, 2022

Product Code 3300; 3931

Part Number 360194-039

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

EMBLEM™ S-ICD

Instructions for Use

Electrode Delivery System

Sep 14, 2022

Product Code 4712

Part Number 92363957-001

Applicable To N/A

Applicable To N/A

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Pacing System Analyzer (PSA)

Mar 01, 2017

Product Code 3300; 3922

Part Number 360164-001

Applicable To Application for use with the LATITUDE™ Programming System

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Electrode Insertion Tool

Nov 01, 2016

Product Code 4711

Part Number 359472-019

Safety Related Revision No

LATITUDE™ Programming System

Programming Manuals

Patient Data Management

Feb 01, 2018

Product Code 3300; 3931

Part Number 360194-020

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD

Instructions for Use

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 17, 2013

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003

Part Number 359060-001

LATITUDE™

Clinician Manuals

LATITUDE NXT Patient Management System

Sep 01, 2016

Product Code 6446; 6448

Part Number 358827-052

Safety Related Revision No

AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD

Reference Guides

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Nov 17, 2013

Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003

Part Number 359211-001

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

Subcutaneous Electrode

Sep 01, 2016

Product Code 3401

Part Number 359469-019

Safety Related Revision No

LATITUDE™ NXT

Clinician Manuals

LATITUDE NXT Patient Management System

Oct 27, 2023

Product Code 6468; 6496; 6446; 00802526613821; 6448; 00802526613814; 6288; 00802526617508; 6288; 00802526617423; 6288; 00802526577376; 6288; 00802526577383; 6288; 00802526616518; 6288; 00802526577413; 6288; 00802526617409; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526617829; 6290; 00802526617836; 6290; 00802526585739; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212

Part Number 92436023-001

Safety Related Revision No

TELIGEN™ 100

Instructions for Use

IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

Nov 09, 2012

Product Code F102; F103; F110; F111

Part Number 357481-067

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Jun 01, 2010

Product Code 2020

Part Number 102099-109

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

ACUITY™ X4 Spiral S;ACUITY™ X4 Spiral L;ACUITY™ X4 Straight

Instructions for Use

Cardiac Lead

Mar 01, 2015

Product Code 4671; 4672; 4674; 4675; 4677; 4678

Part Number 359161-020

Applicable To Coronary Venous; Pace/Sense Lead; IS4 Four-Pole Connector

Safety Related Revision No

LATITUDE™

Clinician Manuals

LATITUDE NXT Patient Management System

Oct 01, 2018

Product Code 6446; 6448

Part Number 358827-075

Safety Related Revision No

AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Nov 01, 2017

Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

Part Number 359406-033

Safety Related Revision No

3300 LATITUDE™ Programming System

Programming Manuals

Network and Connectivity

Jul 31, 2023

Product Code 3924; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

Part Number 92362143-001

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Jul 01, 2014

Product Code 3200

Part Number 104749-004

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

Instructions for Use

PACEMAKER

Oct 06, 2014

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

Part Number 359250-001

INCEPTA™ CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code P162; P163; P165

Part Number 358440-023

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Feb 01, 2013

Product Code 2020

Part Number 102099-010

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

VIGILANT™ CRT-D;MOMENTUM™ EL ICD VR;CHARISMA™ CRT-D;RESONATE™ HF ICD;RESONATE™ CRT-D;PERCIVA™ HF ICD;LATITUDE™ Communicator;MOMENTUM™ CRT-D;RESONATE™ EL ICD DR;PERCIVA™ ICD VR;VIGILANT™ X4 CRT-D;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ EL ICD VR;CHARISMA™ X4 CRT-D;MOMENTUM™ X4 CRT-D;MOMENTUM™ EL ICD DR;RESONATE™ EL ICD VR;LATITUDE™ Programming System;VIGILANT™ EL ICD;CHARISMA™ EL ICD DR;PERCIVA™ ICD DR

Instructions for Use

Oct 12, 2021

Product Code 3300, 6290, D500, D501, D512, D513, D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548, D120, D121, D220, D221, D232, D233, D320, D321, D332, D333, D400, D401, D412, D413, D420, D421, D432, D433, G124, G125, G126, G128, G138, G224, G225, G228,G237 G247, G248, G324, G325, G328, G337, G347, G348, G424, G425, G426, G428, G437, G447, G448

Part Number 360206-019

Safety Related Revision No

ACUITY™ Spiral

Instructions for Use

Implantable Lead

Oct 26, 2023

Product Code 4591; 4592; 4593

Part Number 357272-032

RELIANCE™ 4-FRONT

Patient Information

Cardiac Lead

Jul 25, 2023

Product Code 0672; 0673; 0675; 0676; 0652; 0653; 0657; 0658; 0692; 0693; 0695; 0696; 0636; 0662; 0663; 0665; 0650; 0651; 0654; 0655; 0682; 0683; 0685; 0686

Part Number 51070663-001

COGNIS™ CRT-D;TELIGEN™ ICD;PUNCTUA™;ENERGEN™ CRT-D;INCEPTA™;AUTOGEN™ CRT-D;DYNAGEN™;INOGEN™ CRT-D;ORIGEN™ ICD;ORIGEN™ CRT-D

Reference Guides;Supplemental Updates

Defibrillator

May 28, 2014

Product Code D050; D051; D052; D053; D000; D001; D002; D003; D140; D141; D142; D143; D010; D011; D012; D013; D150; D151; D152; D153; D020; D021; D022; D023; D174; D175; D176; D177; D044; D045; D046; D047; G050; G051; G056; G058; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G175; G177; G179; F050; F051; F052; F053; F140; F141; F142; F143; F160; F161; F162; F163; P052; P053; P142; P143; P162; P163; P165; P106; P107; P108; F102; F103; F110; F111

Part Number 359319-001

Applicable To Reference Guide Update

ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;AUTOGEN™ X4 CRT-D;AUTOGEN™ EL ICD;DYNAGEN™ X4 CRT-D;DYNAGEN™ EL ICD;ENDOTAK RELIANCE™;FINELINE™ II;INGEVITY™ MRI;INOGEN™ EL ICD;INOGEN™ MINI ICD;INOGEN™ X4 CRT-D;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;ORIGEN™ X4 CRT-D;RELIANCE™ 4-FRONT;RESONATE™ CRT-D

MRI Information

Defibrillator

Apr 01, 2015

Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; G058; G148; G158; G179; 0265; 0266; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0654; 0655; 0657; 0658; 0665; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7735; 7736; 7740; 7741; 7742

Part Number 359447-001

Applicable To IMAGEREADY™

Safety Related Revision No

EMBLEM™ S-ICD

Patient Information

EMBLEM™ S-ICD System

Oct 01, 2015

Product Code N/A

Part Number 359285-019

Safety Related Revision No

ENERGEN™ CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code P142; P143

Part Number 358435-018

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

LATITUDE™ Programming System

Programming Manuals

Pacing System Analyzer (PSA)

Jul 07, 2022

Product Code 3300; 3922

Part Number 360164-077

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

DYNAGEN™ X4 CRT-D;AUTOGEN™ X4 CRT-D;ORIGEN™ X4 CRT-D;INOGEN™ X4 CRT-D

Reference Guides;Supplemental Updates;Instructions for Use

Defibrillator

Oct 01, 2014

Product Code N/A

Part Number 359386-001

Applicable To This update provides information about the PaceSafeTM LVAT feature and LV VectorGuideTM for AUTOGENTM X4, DYNAGENTM X4, INOGENTM X4, and ORIGENTM X4 devices.; This update provides information about the PaceSafe™ LVAT feature and LV VectorGuide™ for AUTOGEN™ X4, DYNAGEN™ X4, INOGEN™ X4, and ORIGEN™ X4 devices.

LATITUDE™

Integration Guides

LATITUDE NXT Patient Management System

Oct 01, 2015

Product Code 6624

Part Number 359483-001

Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

Safety Related Revision No

ENDOTAK RELIANCE™

Instructions for Use

Cardiac Lead

Feb 01, 2017

Product Code 0295; 0296; 0292; 0293; 0275; 0276; 0272; 0273

Part Number 358074-119

Applicable To Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Extendable/Retractable Fixation

Safety Related Revision No

EMBLEM™ S-ICD;3300 LATITUDE™ Programming System

Operator's Manual;Programming Manuals;Instructions for Use

Jul 07, 2022

Product Code 3877; 3300

Part Number 92123952-001

RELIANCE™ 4-FRONT

Instructions for Use

Cardiac Lead

Feb 07, 2013

Product Code 0636; 0654; 0655; 0665; 0682; 0683; 0685; 0686

Part Number 350063-045

Applicable To Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Tined Fixation

DYNAGEN™ X4 CRT-D;VIGILANT™ EL ICD;INOGEN™ CRT-D;INGEVITY™ MRI;AUTOGEN™ MINI ICD;VIGILANT™ X4 CRT-D;CHARISMA™ EL ICD;ORIGEN™ CRT-D;INOGEN™ MINI ICD;AUTOGEN™ X4 CRT-D;RESONATE™ HF ICD;ACUITY™ Spiral;ENDOTAK RELIANCE™;AUTOGEN™ CRT-D;MOMENTUM™ EL ICD;DYNAGEN™ CRT-D;RESONATE™ EL ICD;ORIGEN™ MINI ICD;VIGILANT™ CRT-D;EASYTRAK™ 2;INOGEN™ EL ICD;ORIGEN™ EL ICD;RELIANCE™ 4-FRONT;ACUITY™ X4 Spiral L;PERCIVA™ HF ICD;RESONATE™ HF CRT-D;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;RESONATE™ X4 CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ACUITY™ X4 Spiral S;MOMENTUM™ X4 CRT-D;INOGEN™ X4 CRT-D;PERCIVA™ ICD;ORIGEN™ X4 CRT-D;RESONATE™ CRT-D;CHARISMA™ CRT-D;AUTOGEN™ EL ICD;MOMENTUM™ CRT-D;CHARISMA™ X4 CRT-D

MRI Patient Guides;MRI Information

Defibrillator

Feb 01, 2015

Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; D232; D233; D332; D333; D412; D413; D432; D433; D512; D513; D532; D533; G058; G148; G158; G179; G237; G247; G337;G347; G437; G447; G537; G547; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7148; 7735; 7736; 7740; 7741; 7742

Part Number 359446-001

Applicable To ImageReady™ MR Conditional Defibrillation System - Patient Guide for MRI Scans

ACCOLADE™;FORMIO™;VITALIO™;INGENIO™;FORMIO™ MRI;EQUIO™;ALTRUA™ 2;INLIVEN™;ADVANTIO™ MRI;INGENIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

Patient Information

Pacemaker Therapy

Jun 18, 2024

Product Code

Part Number 356395-027

ACCOLADE™ MRI;ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;ADVANTIO™ MRI;ESSENTIO™ MRI;FINELINE™ II;FORMIO™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;VALITUDE™ X4;VISIONIST™ X4;VITALIO™ MRI

MRI Information

Pacemaker

Oct 06, 2014

Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; L111; L131; L210; L211; L231; L310; L311; L331; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 6220; 6221; 6402; 7145; 7731; 7732; 7735; 7736; 7740; 7741; 7742

Part Number 359259-018

Applicable To IMAGEREADY™

CHARISMA™ EL ICD;DYNAGEN™ EL ICD;RESONATE™ HF ICD;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;MOMENTUM™ EL ICD;INOGEN™ EL ICD;AUTOGEN™ EL ICD;RESONATE™ EL ICD;DYNAGEN™ MINI ICD;ORIGEN™ MINI ICD;ORIGEN™ EL ICD;VIGILANT™ EL ICD

Patient Information

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Oct 12, 2021

Product Code

Part Number 356394-040

Safety Related Revision No

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER

May 01, 2013

Product Code 3200

Part Number 104749-001

Applicable To EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM

LATITUDE™ Communicator

Supplemental Updates;Patient Information

Change to your LATITUDE™ Communicator Connection Method; Změňte metodu připojení svého komunikátoru LATITUDE™; Ændring til forbindelsesmåde for din LATITUDE™-kommunikator; Änderungen an Ihrer LATITUDE™ Communicator-Verbindungsmethode; Αλλαγή στη μέθοδο σύνδεσης της Συσκευής επικοινωνίας LATITUDE™; Cambio en el método de conexión del comunicador LATITUDE™; muutos LATITUDE™ yhteydenpitolaitteen yhteysmenetelmään; Modification de la méthode de connexion de votre CommunicatEU; FIr LATITUDE™; A LATITUDE™ kommunikátor csatlakozási módszerének módosítása; Modifica al metodo di connessione del Comunicatore LATITUDE™; wijziging in de verbindingsmethode voor uw LATITUDE Communicator; endring i tilkoblingsmetoden for LATITUDE™-kommunikator; Zmiana metody połączenia komunikatora LATITUDE™; Alteração do método de ligação do sEU; FI Comunicador LATITUDE™; Zmena metódy pripojenia komunikátora LATITUDE™; Ändra anslutningsmetoden i din LATITUDE™ kommunikator

Jul 01, 2022

Product Code 6280, 6288, 6290, 6420, 6443, 6468, 6476, 6481, 6482, 6496, 6498

Part Number 360235-001

Safety Related Revision No

LATITUDE Link™

Instructions for Use;Programming Manuals

LATITUDE Link™ DATA MANAGEMENT SYSTEM

Oct 01, 2015

Product Code 6215; 6216

Part Number 359484-001

Applicable To INSTALLATION AND OPERATION GUIDE

Safety Related Revision No

ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

Instructions for Use

Pacemaker

Mar 02, 2018

Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J062; J063; J064; J065; J067

Part Number 359250-037

Safety Related Revision Yes

ACCOLADE™ MRI;ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;ADVANTIO™ MRI;ESSENTIO™ MRI;FINELINE™ II;FORMIO™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;VALITUDE™ X4;VISIONIST™ X4;VITALIO™ MRI

MRI Information

Pacemaker

Nov 01, 2018

Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; ;L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473;4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4676; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742

Part Number 359259-019

Applicable To IMAGEREADY™

Safety Related Revision Yes

LATITUDE™ Communicator

Patient Information

LATITUDE™ Communicator

Jun 01, 2018

Product Code 6288; 6290

Part Number 359419-020

Safety Related Revision No

VALITUDE™;VISIONIST™ X4;INTUA™;INVIVE™;INLIVEN™;VALITUDE™ X4;VISIONIST™

Instructions for Use

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Jun 18, 2024

Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

Part Number 359254-035

Safety Related Revision Yes

ACUITY™ X4 Spiral L;ACUITY™ X4 Straight;ACUITY™ X4 Spiral S

Instructions for Use

Cardiac Lead

Dec 01, 2023

Product Code 4671; 4672; 4674; 4675; 4677; 4678

Part Number 92035847-019

Safety Related Revision No

LATITUDE™

Integration Guides

LATITUDE Patient Management System

Feb 01, 2015

Product Code 6624

Part Number 350011-018

Applicable To LATITUDE INTEGRATION HL7 SPECIFICATION

Safety Related Revision No

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; Q-TECH™ PROGRAMMER; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Jan 01, 2010

Product Code 2020

Part Number 102099-107

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET,; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®,; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

INGEVITY™ MRI

Instructions for Use

Cardiac Lead

May 01, 2018

Product Code 7731; 7732; 7735; 7736

Part Number 358661-112

Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

Safety Related Revision No

LATITUDE™ Communicator

Patient Information

QUICK START GUIDE

Mar 28, 2024

Product Code 6288; 00802526616518; 6288; 00802526617423; 6288; 00802526617409; 6288; 00802526577383; 6288; 00802526577376; 6288; 00802526617508; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526617829; 6290; 00802526617836

Part Number 92436021-001

Safety Related Revision Blank

RELIANCE™ 4-FRONT

Instructions for Use

Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable Fixation

Jul 14, 2022

Product Code 0657; 0692; 0693; 0658; 0695; 0696; 0652; 0672; 0673; 0653; 0675; 0676

Part Number 350065-075

Safety Related Revision No

LATITUDE™

Clinician Manuals

LATITUDE NXT Patient Management System

Jul 01, 2022

Product Code 6280; 6288; 6290; 6446; 6447; 6448; 6468; 6496; 6498

Part Number 358827-075

Safety Related Revision No

EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

Instructions for Use

SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Sep 14, 2022

Product Code A219; A209

Part Number 92346913-001

Applicable To N/A

Applicable To N/A

Safety Related Revision No

RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

Instructions for Use

Sep 01, 2016

Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

Part Number 360203-001

LATITUDE™ Communicator

Supplemental Updates;Patient Information

komunikátoru LATITUDE™ k ethernetovému adaptéru USB; LATITUDE™ Kommunicatoren – Supplement til USB Ethernet-adapter; LATITUDE™ Communicator-USB-Ethernet-Adapter; Συμπληρωματικό εγχειρίδιο χρήσης Συσκευής επικοινωνίας LATITUDE™ για τον ασθενή Προσαρμογέας Ethernet USB; comunicador del paciente para el adaptador USB de Ethernet LATITUDE™; Communicateur LATITUDE™ pour l´adaptateur Ethernet USB; Comunicatore LATITUDE™ relativo all'adattatore Ethernet USB; LATITUDE™ Communicator USB-ethernetadapter; LATITUDE™-kommunikator – USB-Ethernet-adapter; komunikatora LATITUDE™ dla pacjenta dotyczący adaptera USB do sieci Ethernet; Comunicador LATITUDE™ do Paciente para o Adaptador Ethernet USB; komunikátora LATITUDE™ pre pacienta – adaptér USB Ethernet; USB-Ethernet-adapter till LATITUDE™ kommunikator; LATITUDE™ Communicator - USB Ethernet Adapter; Communicateur LATITUDE™ pour l´adaptateur Ethernet USB

May 20, 2022

Product Code 6293

Part Number 359337-001

Applicable To LATITUDE™ - Communicator Patient Manual Supplement; LATITUDE™ - Suplemento do Manual do Paciente do Comunicador; Dodatek k příručce pro pacienty ke komunikátoru LATITUDE™ k ethernetovému adaptéru USB; Patienthåndbog til LATITUDE™ Kommunicatoren – Supplement til USB Ethernet-adapter; LATITUDE™ Ergänzung zum Communicator- Patientenhandbuch für den USB-Ethernet-Adapter; Συμπληρωματικό εγχειρίδιο χρήσης Συσκευής επικοινωνίας LATITUDE™ για τον ασθενή Προσαρμογέας Ethernet USB; Apéndice del Manual del comunicador del paciente para el adaptador USB de Ethernet LATITUDE™; Supplément au Manuel patient du Communicateur LATITUDE™ pour l´adaptateur Ethernet USB; Supplemento al manuale per il paziente del Comunicatore LATITUDE™ relativo all'adattatore Ethernet USB; Aanvulling op de LATITUDE™ Communicator Patiëntenhandleiding voor de USB-ethernetadapter; Tillegg til pasienthåndbok for LATITUDE™-kommunikator – USB-Ethernet-adapter; Suplement do Instrukcji obsługi komunikatora LATITUDE™ dla pacjenta dotyczący adaptera USB do sieci Ethernet; Suplemento do Manual do Comunicador LATITUDE™ do Paciente para o Adaptador Ethernet USB; Doplnok k manuálu komunikátora LATITUDE™ pre pacienta – adaptér USB Ethernet; Bilaga om USB-Ethernet-adapter till LATITUDE™ kommunikator; LATITUDE™ Communicator - Patient Manual Supplement

FINELINE™ II

Instructions for Use

Cardiac Lead

Mar 01, 2015

Product Code 4456; 4457; 4458; 4459; 4479; 4480

Part Number 355403-222

Applicable To FINELINE™ II STEROX

Safety Related Revision No

Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

Programming Manuals

PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

Aug 01, 2014

Product Code 3200

Part Number 104749-005

Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

ZOOM™ LATITUDE™

Supplemental Updates;Programming Manuals

Programátor / záznamové zařízení / monitor ; Programmer/Recorder/Monitor; Programmier/Aufzeichnungs/Überwachungsgerät ; Προγραμματιστή/Καταγραφέα/Ελεγκτή; Programmer/Recorder/Monitor; programador/registrador/monitor; Programmateur/Enregistreur/Moniteur; Programozó/rekorder/monitor; Programmatore/Registratore/Monitor per l'operatore; Programmer/Recorder/Monitor; Programator/Rejestrator/Monitor; Programador/Registador/Monitor; programátora / nahrávacieho zariadenia / monitoru; Programmerare/Skrivare/Monitor; Programlayıcı/Kaydedici/Monitör; Programmer/Recorder/Monitor; Programmateur/Enregistreur/Moniteur; Programmerer/Opptaker/Monitor

Jan 13, 2021

Product Code 3120

Part Number 359066-002

Applicable To Secure Export Feature Enhancement; Secure Export Feature Enhancement; Amélioration de la Fonction d'Exportation Sécurisée; Zdokonalení funkce bezpečného exportu; Forbedring af sikker eksportfunktion; Erweiterung der sicheren Exportfunktion; Βελτίωση του Χαρακτηριστικού Ασφαλούς Εξαγωγής; Secure Export Feature Enhancement; Mejora de la función de exportación segura; Amélioration de la Fonction d'Exportation Sécurisée; A Biztonságos exportálás funkció bővítése; Miglioramento della funzione di esportazione sicura; Verbetering veilige exportfunctie; Forbedring i funksjonen for sikker eksportering; Rozbudowa funkcji Bezpieczny Eksport; Melhoria da Funcionalidade de Exportação Segura; Vylepšenie bezpečného exportu; Förbättring av funktionen för säker export; Secure Export Feature Enhancement; Güvenli Dışa Aktarma Özelliği Geliştirmesi

COGNIS™ 100-D CRT-D

Reference Guides

CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

Nov 13, 2012

Product Code P106; P107; P108

Part Number 357501-090

Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

LATITUDE™

Clinician Manuals

LATITUDE™ NXT Patient Management System

May 01, 2014

Product Code 6446; 6448

Part Number 358827-020

Safety Related Revision No

FINELINE™ II

Instructions for Use

Cardiac Lead

Jun 21, 2022

Product Code 4456; 4457; 4458; 4459; 4479; 4480

Part Number 355403-222

Applicable To FINELINE™ II STEROX

Safety Related Revision No

IceRod™ 1.5 CX;IceSphere™ 1.5 CX;IceFORCE™ 2.1 CX;IcePearl™ 2.1 CX

Instructions for Use

Cryoablation Needle; Aguja para crioablación; Aiguille de cryoablation; Kryoablationsnadel; Ago per crioablazione; Cryoablatienaald; Agulha de Crioablação

Jun 26, 2024

Product Code H7493961435330; H7493961535730; H7493961836030; H7493970836080; H7493970636060; H7493961636010; H7493962036170; H7493961936040; H7493970736070; H7493970536050; H7493961736020; H7493962136180; H7493963936070; H7493963736050; H7493964036080; H7493963836060

Part Number 51441619-01B

FARAWAVE™

Instructions for Use

Pulsed Field Ablation Catheter

Jul 03, 2024

Product Code M004PFCE41M401; M004PFCE41M402

Part Number 51622663-01A

ZOOM™ LATITUDE™

Programming Manuals

Programmer/Recorder/Monitor

Jul 17, 2024

Product Code 3120

Part Number 357435-150

Safety Related Revision No

Seal™

Instructions for Use

Single Use Biopsy Valve; Válvula para biopsia de un solo uso; Valve de biopsie à usage unique; Biopsieventil für den einmaligen Gebrauch; Valvola monouso per biopsia; Biopsieklep voor eenmalig gebruik; Válvula de Biopsia de Uma Única Utilização

Aug 26, 2024

Product Code SBC-501-100, SBC-501

Part Number 50676680-01B

Applicable To Box 100

Safety Related Revision Blank

LATITUDE™ Communicator

Patient Information

PATIENT MANUAL

Aug 16, 2024

Product Code 6288; 00802526617508; 6288; 00802526617423; 6288; 00802526577376; 6288; 00802526577383; 6288; 00802526616518; 6288; 00802526577413; 6288; 00802526617409; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526617829; 6290; 00802526617836; 6290; 00802526585739; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212

Part Number 92435999-001

Safety Related Revision No

Vercise™ PC;Vercise Gevia™;Vercise Neural Navigator™;Vercise Genus™;Vercise™ Cartesia™;SureTek™

Instructions for Use

Deep Brain Stimulation System

Feb 02, 2022

Product Code DB-1216, DB-1232, DB-1416, DB-1432, DB-1200, DB-1140, DB-2201-30-DC, DB-2201-45-DC, DB-2201-30-AC, DB-2201-45-BC, DB-2202-30, DB-2202-45, DB-4600-C, NM-3138-55, DB-3128-55, DB-3128-95, DB-9418-15, DB-9218-15, DB-9218-55, DB-5170, DB-5132, DB-9315, DB-4120-08, DB-4100-A, SC-4100-A, DB-2500-C, DB-4605-C, SC-4401, SC-4252, DB-4252, SC-4254, DB-4254, DB-5572-1A, DB-5250, DB-5552-1A, DB-5250, DB-5542-1A, DB-5240, DB-64125, DB-64126, NM-6210, DB-6315, NM-6315, NM-6310, NM-6600, DB-6300-C, DB-6200-C, DB-6100-C, NM-6358-SP0, DB-6358-0BK, DB-6358-1BK, DB-6358-5BK, DB-6358-9BK, NM-6350, NM-5312, NM-5305, NM-6305, DB-7164, NM-7164, DB-7164-R, NM-7164-R, DB-7105-N4A, DB-6386, DB-7190, NM-7190, NM-6316, NM-7165, NM-7171

Part Number 92366226-07 Rev A

Applicable To Vercise™ DBS Systems - Information for Prescribers

Safety Related Revision No

Vercise™ PC;Vercise Gevia™;Vercise Neural Navigator™

Installation Guide

Neural Navigator 2 Programming Software

Feb 25, 2021

Product Code DB-7161; DB-7161-R; NM-7161; NM-7161-R; DB-7105-N2

Part Number 91155463-02 A

Applicable To Vercise™ Neural Navigator 2 Installation Guide

Safety Related Revision No

OMG™ Adapter

Instructions for Use

Adapter

Sep 11, 2018

Product Code SC-9315

Part Number 92089844-02 A

Applicable To Precision Spectra™ OMG™ Adapter

Safety Related Revision No

Precision™

Instructions for Use

SCS System

Feb 27, 2015

Product Code SC-1110; SC-2016; SC-2138; SC-2158; SC; 2208; ; SC-2218; SC-2316; SC-2352; SC-2366; SC-3138; SC-3304; SC-3354; SC-3400; SC-5210; SC-5212; SC-5305; SC-5312; ; SC-8216; SC-8120

Part Number 90719336-01B

Applicable To Pautas sobre la realización de RMN de 1,5 teslas para el sistema de estimulación de la médula espinal Precision™

Safety Related Revision No

VISUAL-ICE™

Operator's Manual

Cryoablation System; Dual Cylinder Adapter; Sistema de crioablación; Adaptador para dos cilindros; Système de cryoablation; Adaptateur pour deux bouteilles; Kryoablationssystem; Adapter für Dual-Zylinder; Sistema di crioablazione; Adattatore 2 in 1 per due bombole; Cryoablatiesysteem; Adapter voor dubbele cilinder; Sistema de Crioablação; Adaptador para Duas Botijas

Jun 13, 2024

Product Code H7493960960000; H74939609D60000; H74939609H60000; H74939609R60000; H74939609Z60000; FPRCH4005; FPRCH4008; FPRCH6143; FPRCH6146

Part Number 51342550-01A

IceSphere™ 1.5;IceRod™ 1.5;IceSeed™ 1.5

Instructions for Use

Cryoablation Needle

Jul 27, 2023

Product Code FPRPR3008: FPRPR3070; FPRPR3570; FPRPR3571; FPRPR3572; FPRPR3605; FPRPR3606; FPRPR3607; FPRPR3608; FPRPR4070; FPRPR4518; FPRPR4009; FPRPR3201; FPRPR3202; FPRPR3203; FPRPR3204; FPRPR3258; FPRPR3260; FPRPR3508; FPRPR3510; FPRPR3558; FPRPR3560; FPRPR3561

Part Number LGC20-NDL105 Rev. 01

Safety Related Revision No

ICEfx™ Cryoablation System

Operator's Manual

Cryoablation System; Cart; Dual Cylinder Adapter; Sistema de crioablación; Carro; Adaptador para dos cilindros; Système de cryoablation; Chariot; Adaptateur pour deux bouteilles; Kryoablationssystem; Wagen; Adapter für Dual-Zylinder; Sistema di crioablazione; Carrello; Adattatore 2 in 1 per due bombole; Cryoablatiesysteem; Wagentje; Adapter voor dubbele cilinder; Sistema de Crioablação; Carrinho; Adaptador para Duas Botijas

Jun 13, 2024

Product Code H749396118000; H74939611D8000; H74939611H8000; H74939611R8000; H74939611Z8000; FPRCH4005; FPRCH4008; FPRCH6143; FPRCH6146; FPRCH8010

Part Number 51217944-01B

AutoCap™ RX

Instructions for Use

Integrated Biopsy Cap and Guidewire Locking Device; Dispositivo integrado de bloqueo de guía y tapa para biopsias; Dispositif de verrouillage du guide et capuchon de biopsie intégré; Führungsdraht-Sperrvorrichtung mit integriertem Biopsieverschluss; Tappo per biopsia e dispositivo di bloccaggio del filoguida integrati; Geïntegreerde biopsiedop en vergrendelingshulpmiddel voor de voerdraad; Tampa para Biopsia Integrada e Dispositivo de Bloqueio do Fio-guia

Jun 13, 2024

Product Code M00545100; M00545101; M00545130; M00545131

Part Number 51474204-01Rev.A

Agile™ Esophageal

MRI Information;Instructions for Use

Partially Covered OTW Stent System; Partially Covered OTW Sistema de stent; Partially Covered OTW Système de stent; Partially Covered OTW Stentsystem; Partially Covered OTW Sistema stent; Partially Covered OTW Stentsysteem; Partially Covered OTW Sistema de stent

Jul 12, 2022

Product Code M00517710; M00517720; M00517730; M00517740

Part Number 51095565-01A

Agile™ Esophageal

MRI Information;Instructions for Use

Fully Covered RMV OTW Stent System; Fully Covered RMV OTW Sistema de stent; Fully Covered RMV OTW Système de stent; Fully Covered RMV OTW Stentsystem; Fully Covered RMV OTW Sistema stent; Fully Covered RMV OTW Stentsysteem; Fully Covered RMV OTW Sistema de stent

Jul 12, 2022

Product Code M00517790; M00517800; M00517810; M00517820

Part Number 51252996-01A

RX Locking Device

Instructions for Use

Locking Device For Use with RX Biliary System™, Dispositivo de bloqueo para utilizarse con el RX Biliary System™, Dispositif de verrouillage à utiliser avec RX Biliary System™, Sperrvorrichtung zur Verwendung mit RX Biliary System™, Dispositivo di bloccaggio per l’uso con RX Biliary System™, Borginstrument voor gebruik met het RX Biliary System™, Dispositivo de Bloqueio para Utilização com o RX Biliary System™

Sep 20, 2022

Product Code M00545211, M0054210

Part Number 51088990-01A

Applicable To Box 10

Agile™ Esophageal

MRI Information;Patient Information

Fully Covered RMV OTW Stent System

Feb 12, 2024

Product Code M00517790; M00517800; M00517810; M00517820

Part Number 51396245-01A

Safety Related Revision Blank

Agile™ Esophageal

MRI Information;Patient Information

Fully Covered OTW Stent System

Feb 12, 2024

Product Code M00517750; M00517760; M00517770; M00517780

Part Number 51396244-01A

Safety Related Revision Blank

Agile™ Esophageal

MRI Information;Patient Information

Partially Covered OTW Stent System

Feb 12, 2024

Product Code M00517710, M00517720, M00517730, M00517740

Part Number 51396243-01A

Safety Related Revision Blank

Agile™ Esophageal

MRI Information;Instructions for Use

Fully Covered RMV Stent System; Fully Covered RMV Sistema de stent; Fully Covered RMV Système de stent; Fully Covered RMV Stentsystem; Fully Covered RMV Sistema di stent; Fully Covered RMV Stentsysteem; Fully Covered RMV Sistema de Stent

Jul 22, 2022

Product Code M00517580; M00517590; M00517600; M00517610; M00517620; M00517630; M00517640; M00517650

Part Number 51416368-01A

Safety Related Revision No

Agile™ Esophageal

MRI Information;Instructions for Use

Fully Covered OTW Stent System; Fully Covered OTW Sistema de stent; Fully Covered OTW Système de stent; Fully Covered OTW Stentsystem; Fully Covered OTW Sistema stent; Fully Covered OTW Stentsysteem; Fully Covered OTW Sistema de stent

Jul 12, 2022

Product Code M00517750; M00517760; M00517770; M00517780

Part Number 51252995-01A

Agile™ Esophageal

MRI Information;Instructions for Use

Fully Covered Stent System; Fully Covered Sistema de stent; Fully Covered Système de stent; Fully Covered Stentsystem; Fully Covered Sistema di stent; Fully Covered slokdarmstentsysteem; Fully Covered Sistema de Stent

Jul 22, 2022

Product Code M00517400; M00517410; M00517420; M00517430; M00517440; M00517450; M00517460; M00517470

Part Number 51416367-01A

Safety Related Revision No

Agile™ Esophageal

MRI Information;Instructions for Use

Partially Covered Stent System; Partially Covered Sistema de stent; Partially Covered Système de stent; Partially Covered Stentsystem; Partially Covered Sistema di stent; Partially Covered slokdarmstentsysteem; Partially Covered Sistema de Stent

Jul 22, 2022

Product Code M00517200; M00517210; M00517220; M00517230; M00517240; M00517250; M00517260; M00517270

Part Number 51416369-01A

Safety Related Revision No

AMS 800™ Urinary Control System

Instructions for Use

Sistema de controlo urinário para doentes do sexo feminino e pediátricos

May 01, 2017

Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

Part Number 92116965-01A

Safety Related Revision No

rezūm™

Instructions for Use

Delivery Device Kit for BPH

Apr 22, 2021

Product Code D2201-003

Part Number 3032-004

CXR™ Rear Tip Extender Kit

Instructions for Use

Gamme de prothèses péniennes; Linha de produtos de próteses penianas; Linea di protesi peniene; Línea de prótesis de pene

Jul 01, 2016

Product Code 72403872, 72404320, 72404321, 72404322, 72404323, 72404330

Part Number 230129-01_C

Safety Related Revision No

AMS Ambicor™ Penile Prosthesis

Instructions for Use

Prothèse pénienne gonflable; Auffüllbares Schwellkörperimplantat; Prótese Peniana Insuflável; Prótesis de pene inflable; Protesi peniena gonfiabile

Nov 01, 2016

Product Code 72401450; 72401451; 72401452; 72401453; 72401454; 72401455; 72401456; 72401457; 72401458

Part Number 230119-01E

AMS 800™ Urinary Control System

Instructions for Use

Urinary Control System For Male Patients; Système de contrôle urinaire pour les hommes; Sistema de control urinario para varones; Sistema de controlo urinário para doentes do sexo masculino; System zur Blasenkontrolle für den Mann; Sistema di controllo urinario per pazienti maschi

May 01, 2017

Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

Part Number 92116966-01A

Safety Related Revision No

Disposable Dilators

Instructions for Use

Disposable Dilator; Dilatateur jetable; Dilatador desechable; Dilatador Descartável

Sep 01, 2017

Product Code 720117-01

Part Number 92130122-01A

Safety Related Revision No

AMS 700™ with MS Pump™

Instructions for Use

Penile Prosthesis Product Line; Productlijn penisprothesen; Penisprotesproduktsortiment; Linha de produtos de próteses penianas; Linea di prodotti di protesi peniene; Línea de prótesis de pene; Produktreihe der Schwellkörperimplantate; Gamme de prothèses péniennes

Aug 01, 2017

Product Code 72404250; 72404251; 72404252; 72404253; 72404255; 72404256; 72404257; 72040258; 72404252-10; 72404253-12; 72404300; 72404301; 72404302; 72404303; 72404305; 72404306; 72404307; 72404308; 72404302-10; 72404303-12; 72404241; 72404242; 72404243; 72404244; 72404291; 72404292; 72404293; 72404294; 72404230; 72404231; 72404232; 72404233; 72404234; 72404235; 72404236; 72404237; 72404238; 72404239; 72404232‐10; 72404233‐12; 72404234‐14; 72404280; 72404281; 72404282; 72404283; 72404284; 72404285; 72404286; 72404287; 72404288; 72404289; 72404282-10; 72404283-12; 72404284-14; 72404171; 72404172; 72404173; 72404174; 72404175; 72404271; 72404272; 72404273; 72404274; 72404275; 72404260; 72404261; 72404262; 72404263; 72404264; 72404265; 72404266; 72404267; 72404268; 72404269; 72404010; 72404011; 72404012; 72404013; 72404014; 72403872; 720185‐01; 72400095; 72404155; 72404156; 72404209; 72404161; 72404162; 72404310; 72401850; 72404043; 720182-01; 72404320; 72404321; 72404322; 72404323; 72404324; 72404325; 72404326; 72404330

Part Number 92162915-01A

Safety Related Revision No

Ambicor™

Instructions for Use

Inflatable Penile Prosthesis; Prótesis de pene inflable; Prothèse pénienne gonflable; Prótese Peniana Insuflável

Nov 01, 2019

Product Code 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458, 72402890

Part Number 50654573-01B

Safety Related Revision No

AMS 800™ Urinary Control System

Instructions for Use

Artificial Urinary Sphincter; Esfínter urinario artificial; Sfintere urinario artificiale; Sphincter urinaire artificiel; Künstlicher Blasenschließmuskel; Esfíncter urinário artificial

Feb 01, 2017

Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

Part Number 1003182A

Applicable To For Female and Pediatric Patients; Para mujeres y niños; Per pazienti femmine e pediatrici; Pour les femmes et les enfants; Für Frauen und Kinder; Para doentes do sexo feminino e pediátricos

AMS 800™ Urinary Control System

Programming Manuals

Urinary Control SystemFor Male, Female, and Pediatric Patients

May 01, 2017

Product Code 72400023, 72400024. 72400025, 72400098, 72400160, 72400161, 72400162, 72400163, 72400164, 72400165, 72400166, 72400167, 72400168, 72400170, 72400172, 72400174, 72401685, 72404127, 72404130, 72404131, 72404132, 72404133, 72404134, 72404135, 72404136, 72404137, 72404138, 72404140, 72404142, 72404144, 720066-01, 720133-01, 720157-01

Part Number 92116967-01A

Safety Related Revision No

AMS 800™ Urinary Control System

Instructions for Use

Artificial Urinary Sphincter; Esfíncter urinário artificial; Sphincter urinaire artificiel; Esfínter urinario artificial; Künstlicher Blasenschließmuskel; Sfintere urinario artificiale

Feb 01, 2017

Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

Part Number 1003181A

Applicable To For Male Patients; Para doentes do sexo masculino; Pour les hommes; Para varones; Für den Mann; Per pazienti maschi

AMS 800™ Urinary Control System

Programming Manuals

Artificial Urinary Sphincter

Jul 01, 2016

Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

Part Number 1002533B

Applicable To For Male, Female, and Pediatric Patients

AMS Ambicor™ Penile Prosthesis

Instructions for Use

Penile Prosthesis; Prothèse pénienne; Prótesis de pene; Prótese Peniana; Protesi peniena; Schwellkörperimplantat

Aug 01, 2017

Product Code 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458, 72402890

Part Number 92113093-01A

Safety Related Revision No

Disposable Dilators

Instructions for Use

Einweg-Dilatator; Dilatateur jetable; Dilatador desechable; Dilatatore monouso; Disposable Dilator; Dilatador Descartável

Nov 01, 2016

Product Code 720117-01

Part Number 230118-01D

Disposable Dilators

Instructions for Use

Disposable Dilator; Einweg-Dilatator; Dilatador desechable; Dilatateur jetable; Dilatatore monouso; Dilatador Descartável

Apr 08, 2021

Product Code 720131-01; 720117-01

Part Number 92130122-01B

Applicable To CE 2797 Legal Manufacturer—AMS; CE 2797 Berechtigter Hersteller—AMS; CE 2797 Fabricante legal—AMS; CE 2797 Fabricant légal—AMS; CE 2797 Fabbricante legale—AMS; CE 2797 Fabricante Legal—AMS

Safety Related Revision No

rezūm™

Instructions for Use

Generator

Apr 22, 2021

Product Code G2200-0031

Part Number 3033-001

AMS™ Quick Connect Assembly Tool

Instructions for Use

Sistema de Conexão Rápida sem Sutura; Système de connexion rapide (sans fil); Nahtlose Schnellkonnektoren mit Fenster; Conectores rápidos sin sutura; Conectores rápidos sin sutura; Connettori rapidi a finestra

Nov 01, 2016

Product Code 72400023, 72400024, 72400025, 72400095, 72400098, 72400160, 72400161, 72400162, 72400163, 72400164, 72400165, 72400166, 72400167, 72400168, 72400170, 72400172, 72400174, 72401685, 72401850, 72404010, 72404011, 72404012, 72404013, 72404014, 72404127, 72404130, 72404131, 72404132, 72404133, 72404134, 72404135, 72404136, 72404137, 72404138, 72404140, 72404142, 72404144, 72404155, 72404156, 72404161, 72404162, 72404171, 72404172, 72404173, 72404174, 72404175, 72404209, 72404230, 72404231, 72404232, 72404233, 72404234, 72404235, 72404236, 72404237, 72404238, 72404239, 72404241, 72404242, 72404243, 72404244, 72404250, 72404251, 72404252, 72404253, 72404255, 72404256, 72404257, 72404258, 72404260, 72404261, 72404262, 72404263, 72404264, 72404265, 72404266, 72404267, 72404268, 72404269, 72404271, 72404272, 72404273, 72404274, 72404275, 72404280, 72404281, 72404282, 72404283, 72404284, 72404285, 72404286, 72404287, 72404288, 72404289, 72404291, 72404292, 72404293, 72404294, 72404300, 72404301, 72404302, 72404303, 72404305, 72404306, 72404307, 72404308, 72404310, 720133-01, 720157-01, 720182-01, 720185-01, 72404232-10, 72404233-12, 72404234-14, 72404252-10, 72404253-12, 72404282-10, 72404283-12, 72404284-14, 72404302-10, 72404303-12

Part Number 230128-01_C

Safety Related Revision No

rezūm™

Instructions for Use

Delivery Device Kit for BPH; Kit dispositivo di rilascio per BPH; Kit de dispositif de mise en place pour BPH; Kit do Dispositivo de Administração para BPH; Applikationssystemsatz für BPH; Kit de dispositivo de introducción para BPH; Plaatsingsinstrument voor BPH

May 23, 2022

Product Code D2201

Part Number 50966794-01A

RHYTHMIA HDx™

Instructions for Use

Mapping System

Aug 16, 2023

Product Code M004RA5010A0; M004RA5010I0; M004RA5110A0; M004RA5110I0; M004RA9000ECG30; M004RA9000ECG60; M004RA9000ICAB30; M004RA9000ICAB60; M004RA9000ICM30; M004RA9000ICM60; M004RA9100ECG30; M004RA9100ECG60; M004RA9100IC30; M004RA9100IC60; M004RALRCBL20; M004RAMMTIPS220; M004RH11120; M004RH11220; M004RH15010; M004RA71010; M004RBEVAL2END0; M004RH10200; M004RH1020H0; M004RH1020R0; M004RH20010; M004RH20020; M004RH40100; M004RH14010; M004RH14510; M004RA60010; M004RA62010; M004RH11020; M004RBINSTALL2EN0; 1964-01; 1964-00; 1963-01; 1963-00; 1962-00; 1962-01; 1961-00; 1961-01; 1945-00; 1945-01; 1944-00; 1944-01; 2064-00; 2064-01; 1964-02; 1943-00; 1943-01; 1942-01; 1941-01; 1940-00; 1940-01; 1939-00; 1939-01; 1964-04; 1943-04; 1943-03

Part Number 51124867-01A

Koala™

Instructions for Use

Cleaning Sponge plus Pure™ Enzymatic; Esponja de limpieza y detergente enzimático Pure™; Éponges nettoyante imprégnée de détergent enzymatique Pure™; Reinigungsschwamm plus Pure™-Enzymreiniger; Spugna per pulizia con soluzione enzimatica Pure™; Reinigingssponsje met Pure™ enzymatisch reinigingsmiddel; Rengøringssvamp med Pure™-enzymrengøringsmiddel; Σπόγγος καθαρισμού συν ενζυματικό Pure™; Esponja de Limpeza com Solução Enzimática Pure™; Rengöringssvamp och Pure™ enzymatiskt rengöringsmedel; Törlőszivacs Pure™ enzimatikus anyaggal; Čisticí houbička s enzymatickým roztokem Pure™ Enzymatic; Czyszczenie Sponge plus Pure™ Enzymatic; Rengjøringssvamp plus Pure™ enzymatisk; Puhdistussieni ja entsymaattinen Pure™-pesuaine; Burete de curățare plus Pure™, enzimatic; Čistiaca špongia s enzymatickým prípravkom Pure™; Почистваща гъба плюс детергент Pure™ Enzymatic; Spužva za čišćenje s enzimskim sredstvom Pure™; Ensümaatiline puhastuskäsn Pure™; Fermentatīvs tīrīšanas sūklis plus Pure™; Valymo kempinė Plus „Pure™ Enzymatic“; Čistilna gobica plus encimsko čistilo Pure™

Nov 04, 2024

Product Code SES-240-50

Part Number 51096726-01A

Applicable To Box 50

Safety Related Revision Blank

BIB Intragastric Balloon System

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-40800

Part Number GRF-00200-00R05

Orbera® Gastric Balloons

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-50012

Part Number GRF-00377-00R10

BIB Intragastric Balloon System

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-40800

Part Number GRF-00200-00R09

BIB Intragastric Balloon System

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-40800

Part Number GRF-00200-00R08

Orbera® Gastric Balloons

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-50012

Part Number GRF-00377-00R13

Orbera® Gastric Balloons

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-50012

Part Number GRF-00377-00R09

Orbera® Gastric Balloons

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-50012

Part Number GRF-00377-00R12

BIB Intragastric Balloon System

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-40800

Part Number GRF-00200-00R06

BIB Intragastric Balloon System

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-40800

Part Number GRF-00200-00R10

BIB Intragastric Balloon System

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-40800

Part Number GRF-00200-00R07

Orbera® Gastric Balloons

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-50012

Part Number GRF-00377-00R14

Orbera® Gastric Balloons

Instructions for Use

Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

Oct 29, 2024

Product Code B-50012

Part Number GRF-00377-00R11

ACURATE neo2™

Instructions for Use

Transfemoral Delivery System; Sistema introductor transfemoral; Système de mise en place transfémorale; Sistema de Administração Transfemoral Loading Kit; Kit de Carga; Kit de chargement; Kit de carregamento

Oct 31, 2024

Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

Part Number 51081295-01

OverTube™ Endoscopic Access System

Instructions for Use

Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

Oct 24, 2024

Product Code 10811955020701; OVT-027-160

Part Number GRF-00081-00R09

OverTube™ Endoscopic Access System

Instructions for Use

Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

Oct 24, 2024

Product Code 10811955020701; OVT-027-160

Part Number GRF-00081-00R08

OverTube™ Endoscopic Access System

Instructions for Use

Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

Oct 24, 2024

Product Code 10811955020701; OVT-027-160

Part Number GRF-00081-00R07

OverStitch™ 2-0 Polypropylene Suture

Instructions for Use

Polypropylene Suture; Полипропиленов конец; polipropilenski kirurški konac; Polypropylénová sutura; Polypropylensutur; Polypropyleen hechtdraad; Polüpropüleenist haavaõmblus; Polypropeeniommel; Suture en polypropylène; Polypropylenfaden; Ράμμα πολυπροπυλενίου; Polipropilén varrat; Sutura in polipropilene; Polipropilēna šuve; Polipropileno siūlas; Polypropylensutur; Szew polipropylenowy; Sutura de polipropileno; Sutură din polipropilenă; Sutura de polipropileno; Polypropylénový šijací materiál; Polipropilenska sutura; Polypropylensutur; Polipropilen Sütür

Oct 24, 2024

Product Code 00811955020735; PLY-G02-020-APL

Part Number GRF-00555-00R01

OverTube™ Endoscopic Access System

Instructions for Use

Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

Oct 24, 2024

Product Code 10811955020701; OVT-027-160

Part Number GRF-00081-00R10

OverTube™ Endoscopic Access System

Instructions for Use

Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

Oct 24, 2024

Product Code 10811955020701; OVT-027-160

Part Number GRF-00081-00R11

LATITUDE™ NXT

Clinician Manuals

LATITUDE NXT Patient Management System

Sep 27, 2024

Product Code 6288; 6290; 6446; 6468; 6496

Part Number 51467383-001

Safety Related Revision No

Acquire™ S

Instructions for Use

Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device; Dispositivo de biopsia con aguja fina (FNB) por ecografía endoscópica; Dispositif de biopsie par aiguille fine (BAF) sous échoendoscopie; Vorrichtung zur endoskopischen Ultraschall-Feinnadelbiopsie (FNB); Dispositivo di aspirazione con ago sottile per biopsia endoscopica a ultrasuoni (FNB); Hulpmiddel voor ultrasone endoscopische fijnenaaldbiopsie (FNB); Dispositivo de Biopsia por Agulha Fina (FNB) para Ecografia Endoscópica

Sep 05, 2024

Product Code M00555660; M00555661; M00555640; M00555641

Part Number 51648291-01A

MDU5 PLUS™ Sterile Bag ;OptiCross™ 6 HD;OptiCross™ HD

Instructions for Use

60 MHz Coronary Imaging Catheters; Catéteres para toma de imágenes coronarias de 60 MHz; Cathéters d'imagerie coronarienne 60 MHz; 60 MHz Koronar-Bildgebungskatheter; Cateteri per imaging coronarico da 60 MHz; 60 MHz coronaire echografiekatheters; Cateteres Ecográficos Coronários de 60 MHz Sterile Bag for MDU5 PLUS Motordrive Unit; Bolsa estéril para unidad motora MDU5 PLUS; Poche stérile pour unité d’entraînement à moteur MDU5 PLUS; Steriler Beutel für MDU5 PLUS Motorantriebseinheit; Sacchetto sterile per unità di azionamento MDU5 PLUS; Steriele zak voor MDU5 PLUS-motoraandrijfeenheid; Bolsa Esterilizada da Unidade de Acionamento do Motor MDU5 PLUS

Sep 12, 2024

Product Code H74939352020; H74939352030; H74939354060; H74939354070

Part Number 51393430-01B

LATITUDE™

Integration Guides

LATITUDE INTEGRATION IDCO SPECIFICATION; LATITUDE Patient Management System

Sep 27, 2024

Product Code 6455; 6624; 6446; 6448; 6460

Part Number 92290289-001

Safety Related Revision No

LATITUDE™

Clinician Manuals;Integration Guides

LATITUDE NXT Patient Management System

Sep 27, 2024

Product Code 6455; 6624; 6446; 6448; 6460

Part Number 92290311-001

Applicable To LATITUDE™ NXT- LATITUDE INTEGRATION HL7 SPECIFICATION

LUX-Dx™

Instructions for Use

LUX-Dx™ Insertable Cardiac Monitor System

Sep 27, 2024

Product Code M301; 2925; 2935; 7246

Part Number 92216690-001

LUX-Dx™

MRI Information

IMAGEREADY™ MR Conditional ICM System

Sep 27, 2024

Product Code M301

Part Number 92216913-001

LUX-Dx™

Instructions for Use

LUX-Dx™ Insertable Cardiac Monitor System

Sep 27, 2024

Product Code M301; 2925; 2935; 7246

Part Number 51676508-001

OverStitch™ Suture Cinch;OverStitch™ Endoscopic Suturing System;OverStitch™ 2-0 Polypropylene Suture;OverStitch™ Tissue Helix

Instructions for Use

Endoscopic Suturing System; Система за ендоскопско съшиване; sustav za endoskopsko šivanje; Systém pro endoskopické šití; Endoskopisk sutureringssystem; Endoscopisch hechtsysteem; Endoskoopiline haavaõmblemise süsteem; Endoskooppinen ommeljärjestelmä; Système de suture endoscopique; Endoskopisches Fadensystem; Σύστημα ενδοσκοπικής συρραφής; Endoszkópos varrórendszer; Sistema di sutura endoscopico; Endoskopiskā šuvju uzlikšanas sistēma; Endoskopinė siuvimo sistema; Endoskopisk sutureringssystem; System do endoskopowego zakładania szwów; Sistema de sutura endoscópica; Systém na endoskopické šitie; Endoskopski sistem za suturo; Sistema de sutura endoscópico; Endoskopiskt sutursystem; Endoskopik Sütür Sistemi Polypropylene Suture; Полипропиленов конец; polipropilenski kirurški konac; Polypropylénová sutura; Polypropylensutur; Polypropyleen hechtdraad; Polüpropüleenist haavaõmblus; Polypropeeniommel; Suture en polypropylène; Polypropylenfaden; Ράμμα πολυπροπυλενίου; Polipropilén varrat; Sutura in polipropilene; Polipropilēna šuve; Polipropileno siūlas; Polypropylensutur; Szew polipropylenowy; Sutura de polipropileno; Polypropylénový šijací materiál; Polipropilenska sutura; Sutura de polipropileno; Polypropylensutur; Polipropilen Sütür Suture Cinch; Структура на съшиване; cinch za zatezanje šavova; Sutura Cinch; Sutur Cinch; Hecht-cinch; Õmbluse pinguti; Ommellangan kiristin; Tenseur de suture; Faden-Cinch; Συγκρατητήρας ραμμάτων; Cinch varrat; Cinch per sutura; Šuves stiprinājums; Siūlo spaustukas; Suturfeste; Cinch do zakładania szwów; Cinta de Sutura; Šijací materiál na uzatváranie; Zategnjena sutura; Ajuste de sutura; Cinch-sutur; Sütür Kancası Tissue HeliX; Тъкан HeliX; spirala za zahvaćanje tkiva; Tkáň HeliX; Vævshelix; Weefsel-HeliX; Koe HeliX; Kudos HeliX; Préhenseur hélicoïdal pour tissus Tissue HeliX; Gewebe-Helix; Έλικα ιστού; Szövet HeliX; Tessuto HeliX; Audu paņemšanas spirālveida ierīce; „HeliX“ audinys; HeliX til vev; HeliX do tkanek; Tecido HeliX; HeliX na tkanivo; Tkivna vijačnica; Tejido HeliX; Vävnads-HeliX; Doku Heliksi

Oct 09, 2024

Product Code 10811955020664; ESS-G02-160; 00811955020735; PLY-G02-020-APL; CNH-G01-000; 10811955020671; THX-165-028; 10811955020688

Part Number GRF-00553-00R01

Applicable To OverStitch Sutures are associated with 3 different products OverStitch, OverStitch Sx, and Overstitch NXT.; OverStitch Suture Cinch is associated with 4 different products OverStitch, OverStitch Sx, Overstitch NXT. and X-Tack.; Suture have a standalone IFU but the user should still reverence the OverStitch, Sx, or NXT IFU for use context.

OverStitch™ Suture Cinch;OverStitch Sx™ Endoscopic Suturing System;OverStitch™ 2-0 Polypropylene Suture;OverStitch™ Tissue Helix

Instructions for Use

Endoscopic Suturing System; Система за ендоскопско съшиване; sustav za endoskopsko šivanje; Systém pro endoskopické šití; Endoskopisk sutureringssystem; Endoscopisch hechtsysteem; Endoskoopiline haavaõmblemise süsteem; Endoskooppinen ommeljärjestelmä; Système de suture endoscopique; Endoskopisches Fadensystem; Σύστημα ενδοσκοπικής συρραφής; Endoszkópos varrórendszer; Sistema di sutura endoscopico; Endoskopiskā šuvju uzlikšanas sistēma; Endoskopinė siuvimo sistema; Endoskopisk sutureringssystem; System do endoskopowego zakładania szwów; Sistema de sutura endoscópica; Sistem de suturare endoscopic; Systém na endoskopické šitie; Endoskopski sistem za suturo; Sistema de sutura endoscópico; Endoskopiskt sutursystem; Endoskopik Sütür Sistemi; Polypropylene Suture; Полипропиленов конец; polipropilenski kirurški konac; Polypropylénová sutura; Polypropylensutur; Polypropyleen hechtdraad; Polüpropüleenist haavaõmblus; Polypropeeniommel; Suture en polypropylène; Polypropylenfaden; Ράμμα πολυπροπυλενίου; Polipropilén varrat; Sutura in polipropilene; Polipropilēna šuve; Polipropileno siūlas; Polypropylensutur; Szew polipropylenowy; Sutura de polipropileno; Sutură din polipropilenă; Polypropylénový šijací materiál; Polipropilenska sutura; Sutura de polipropileno; Polypropylensutur; Polipropilen Sütür; Suture Cinch; Структура на съшиване; cinch za zatezanje šavova; Sutura Cinch; Sutur Cinch; Hecht-cinch; Õmbluse pinguti; Ommellangan kiristin; Tenseur de suture; Faden-Cinch; Συγκρατητήρας ραμμάτων; Cinch varrat; Cinch per sutura; Šuves stiprinājums; Siūlo spaustukas; Suturfeste; Cinch do zakładania szwów; Cinta de Sutura; Sutură Cinch; Šijací materiál na uzatváranie; Zategnjena sutura; Ajuste de sutura; Cinch-sutur; Sütür Kancası; Tissue HeliX; Тъкан HeliX; spirala za zahvaćanje tkiva; Tkáň HeliX; Vævshelix; Weefsel-HeliX; Koe HeliX; Kudos HeliX; Préhenseur hélicoïdal pour tissus Tissue HeliX; Gewebe-Helix; Έλικα ιστού; Szövet HeliX; Tessuto HeliX; Audu paņemšanas spirālveida ierīce; „HeliX“ audinys; HeliX til vev; HeliX do tkanek; Tecido HeliX; Țesut HeliX; HeliX na tkanivo; Tkivna vijačnica; Tejido HeliX; Vävnads-HeliX; Doku Heliksi

Oct 09, 2024

Product Code 10811955020718; ESS-G02-Sx1; 00811955020735; PLY-G02-020-APL; CNH-G01-000; 10811955020671; THX-165-028; 10811955020688

Part Number GRF-00554-00R01

EMBLEM™ S-ICD;3300 LATITUDE™ Programming System

Operator's Manual;Programming Manuals;Instructions for Use

EMBLEM™ S-ICD

Nov 12, 2024

Product Code 3877; 3300

Part Number 92123952-028

Safety Related Revision No

3300 LATITUDE™ Programming System

Operator's Manual;Programming Manuals

Pacing System Analyzer (PSA)

Nov 12, 2024

Product Code 3922; 3300

Part Number 92402515-028

Safety Related Revision No

3300 LATITUDE™ Programming System

Operator's Manual;Programming Manuals

Patient Data Management

Nov 12, 2024

Product Code 3931; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

Part Number 92411965-001

Applicable To Application for use with the LATITUDE™ Programming System

Safety Related Revision No

3300 LATITUDE™ Programming System

Operator's Manual;Programming Manuals

Network and Connectivity

Nov 12, 2024

Product Code 3924; 3300

Part Number 92362143-028

Safety Related Revision No

3300 LATITUDE™ Programming System

Operator's Manual;Programming Manuals

LATITUDE™ Programming System

Nov 12, 2024

Product Code 3300; 3154; 6629; 3889

Part Number 92362142-055

Safety Related Revision No

SYNERGY™ SHIELD

Patient Information;MRI Patient Guides

Everolimus-Eluting Platinum Chromium Coronary Stent System

Nov 15, 2024

Product Code H7493966608220; H7493966608250; H7493966608270; H7493966608300; H7493966608350; H7493966608400; H7493966612220; H7493966612250; H7493966612270; H7493966612300; H7493966612350; H7493966612400; H7493966612450; H7493966612500; H7493966616220; H7493966616250; H7493966616270; H7493966616300; H7493966616350; H7493966616400; H7493966616450; H7493966616500; H7493966620220; H7493966620250; H7493966620270; H7493966620300; H7493966620350; H7493966620400; H7493966620450; H7493966620500; H7493966624220; H7493966624250; H7493966624270; H7493966624300; H7493966624350; H7493966624400; H7493966624450; H7493966624500; H7493966628220; H7493966628250; H7493966628270; H7493966628300; H7493966628350; H7493966628400; H7493966628450; H7493966628500; H7493966632220; H7493966632250; H7493966632270; H7493966632300; H7493966632350; H7493966632400; H7493966632450; H7493966632500; H7493966638220; H7493966638250; H7493966638270; H7493966638300; H7493966638350; H7493966638400; H7493966648250; H7493966648270; H7493966648300; H7493966648350; H7493966648400;

Part Number 51496008-01A

ACURATE neo2™

Patient Information

Heart Valve

Nov 15, 2024

Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

Part Number 51697208-01A

ACURATE Prime™

Instructions for Use

Aortic Valve; Válvula aórtica; Valvule aortique; Válvula Aórtica

Nov 20, 2024

Product Code H749396822325; H749396822729; H74939690230; H74939690250; H74939690270; H74939690290; H749396942325; H749396942729;

Part Number 51768556-01A

myLUX™;LUX-Dx™

Patient Information

myLUX™ Patient App for Insertable Cardiac Monitor

Nov 17, 2024

Product Code M301; 2925; 6259

Part Number 51583243-001

Safety Related Revision No

myLUX™;LUX-Dx™

Instructions for Use

Magnet in shielded box Aimant dans coffret blindé Magnet in abgeschirmtem Gehäuse Magnete in scatola schermata Magneet in afgeschermde doos Imán en caja aislante

Nov 17, 2024

Product Code 6386

Part Number 50679640-002

Safety Related Revision Blank

ACURATE neo2™

Instructions for Use

Aortic Valve; Válvula aórtica; Valvule aortique; Válvula Aórtica

Nov 15, 2024

Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

Part Number 51561810-01A