This webpage provides access to prior revisions of Directions for Use and product manuals for products sold in the European Union where this literature was exclusively provided electronically after 01 March, 2013.
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
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
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
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
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
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
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
Quick Start Guide;Patient Information
QUICK START GUIDE
Aug 16, 2024
Product Code 6288; 00802526577413; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212; 6290; 00802526585739
Part Number 92446237-001
Safety Related Revision Blank
Instructions for Use
Delivery Device Kit for BPH
Apr 22, 2021
Product Code D2201-003
Part Number 3032-004
Instructions for Use
Drug-Eluting Vascular Stent System
Nov 28, 2024
Product Code H74939295600470; H74939295600670; H74939295600870; H74939295601070; H74939295601270; H74939295601570; H74939295600410; H74939295600610; H74939295600810; H74939295601010; H74939295601210; H74939295601510; H74939295700470; H74939295700670; H74939295700870; H74939295701070; H74939295701270; H74939295701570; H74939295700410; H74939295700610; H74939295700810; H74939295701010; H74939295701210; H74939295701510; 08714729876755; 08714729876762; 08714729876779; 08714729876786; 08714729876793; 08714729876809; 08714729876816; 08714729876823; 08714729876830; 08714729876847; 08714729876854; 08714729876861; 08714729876878; 08714729876885; 08714729876892; 08714729876908; 08714729876915; 08714729876922; 08714729876939; 08714729876946; 08714729876953; 08714729876960; 08714729876977; 08714729876984
Part Number 51438473-01A
Instructions for Use
Drug-Eluting Vascular Stent System
Nov 29, 2024
Product Code H74939295600470; H74939295600670; H74939295600870; H74939295601070; H74939295601270; H74939295601570; H74939295600410; H74939295600610; H74939295600810; H74939295601010; H74939295601210; H74939295601510; H74939295700470; H74939295700670; H74939295700870; H74939295701070; H74939295701270; H74939295701570; H74939295700410; H74939295700610; H74939295700810; H74939295701010; H74939295701210; H74939295701510
Part Number 51130986-01B
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
Mar 19, 2025
Product Code B-50012
Part Number GRF-00377-00R15
Instructions for Use
Self-Expanding Stent System
Mar 17, 2025
Product Code H74939180050270; H74939180051070; H74939180051270; H74939180051570; H74939180051870; H74939180052070; H74939180054070; H74939180056070; H74939180058070; H74939180060270; H74939180061070; H74939180061270; H74939180061570; H74939180061870; H74939180062070; H74939180064070; H74939180066070; H74939180068070; H74939180070270; H74939180071070; H74939180071270; H74939180071570; H74939180071870; H74939180072070; H74939180074070; H74939180076070; H74939180078070; H74939180080270; H74939180081070; H74939180081270; H74939180081570; H74939180081870; H74939180082070; H74939180084070; H74939180086070; H74939180088070; H74939181050230; H74939181051030; H74939181051230; H74939181051530; H74939181051830; H74939181052030; H74939181054030; H74939181056030; H74939181058030; H74939181060230; H74939181061030; H74939181061230; H74939181061530; H74939181061830; H74939181062030; H74939181064030; H74939181066030; H74939181068030; H74939181070230; H74939181071030; H74939181071230; H74939181071530; H74939181071830; H74939181072030; H74939181074030; H74939181076030; H74939181078030; H74939181080230; H74939181081030; H74939181081230; H74939181081530; H74939181081830; H74939181082030; H74939181084030; H74939181086030; H74939181088030; 08714729792062; 08714729792079; 08714729792086; 08714729792093; 08714729792109; 08714729792116; 08714729792123; 08714729792130; 08714729792147; 08714729792154; 08714729792161; 08714729792178; 08714729792185; 08714729792192; 08714729792208; 08714729792215; 08714729792222; 08714729792239; 08714729792246; 08714729792253; 08714729792260; 08714729792277; 08714729792284; 08714729792291; 08714729792307; 08714729792314; 08714729792321; 08714729792338; 08714729792345; 08714729792352; 08714729792369; 08714729792376; 08714729792383; 08714729792390; 08714729792406; 08714729792413; 08714729792420; 08714729792437; 08714729792444; 08714729792451; 08714729792468; 08714729792475; 08714729792482; 08714729792499; 08714729792505; 08714729792512; 08714729792529; 08714729792536; 08714729792543; 08714729792550; 08714729792567; 08714729792574; 08714729792581; 08714729792598; 08714729792604; 08714729792611; 08714729792628; 08714729792635; 08714729792642; 08714729792659; 08714729792666; 08714729792673; 08714729792680; 08714729792697; 08714729792703; 08714729792710; 08714729792727; 08714729792734; 08714729792741; 08714729792758; 08714729792765; 08714729792772
Part Number 51188989-01B
Instructions for Use
Self-Expanding Stent System
Mar 19, 2025
Product Code H74939180050270; H74939180051070; H74939180051270; H74939180051570; H74939180051870; H74939180052070; H74939180054070; H74939180056070; H74939180058070; H74939180060270; H74939180061070; H74939180061270; H74939180061570; H74939180061870; H74939180062070; H74939180064070; H74939180066070; H74939180068070; H74939180070270; H74939180071070; H74939180071270; H74939180071570; H74939180071870; H74939180072070; H74939180074070; H74939180076070; H74939180078070; H74939180080270; H74939180081070; H74939180081270; H74939180081570; H74939180081870; H74939180082070; H74939180084070; H74939180086070; H74939180088070; H74939181050230; H74939181051030; H74939181051230; H74939181051530; H74939181051830; H74939181052030; H74939181054030; H74939181056030; H74939181058030; H74939181060230; H74939181061030; H74939181061230; H74939181061530; H74939181061830; H74939181062030; H74939181064030; H74939181066030; H74939181068030; H74939181070230; H74939181071030; H74939181071230; H74939181071530; H74939181071830; H74939181072030; H74939181074030; H74939181076030; H74939181078030; H74939181080230; H74939181081030; H74939181081230; H74939181081530; H74939181081830; H74939181082030; H74939181084030; H74939181086030; H74939181088030
Part Number 51438005-01A
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