Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

Boston Scientific Corporation

MN/USA

2124215

2026

implantable pulse generator, pacemaker (non-crt) - ACCOLADE; ADVANTIO; ALTRUA 2; ALTRUA 20; ALTRUA 40; ALTRUA 60; ESSENTIO; FORMIO; INGENIO; PROPONENT; Screw Cap Wrench; VITALIO

Specification Developer

implantable pulse generator, pacemaker (non-crt) - AUTOGEN EL; DYNAGEN EL; DYNAGEN MINI; ENERGEN; INCEPTA; INOGEN EL; INOGEN MINI; MOMENTUM EL ICD; PERCIVA HF ICD; PERCIVA ICD; PUNCTUA; RESONATE EL ICD; RESONATE HF ICD; VIGILIANT EL ICD

Manufacturer

implantable pulse generator, pacemaker (non-crt) - ACUITY Spiral; ACUITY X4 Flushing Tool/Wire Guide; ACUITY X4 Spiral; ACUITY X4 Straight; AUTOGEN CRT-D; AUTOGEN X4 CRT-D; Bi Directional Torque Wrench; CONTAK CD Software Application; CONTAK CD2 Software Application; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D; INCEPTA CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; Lead Cap; MOMENTUM CRT-D; MOMENTUM X4 CRT-D; PUNCTUA CRT-D; RESONATE CRT-D; RESONATE HF CRT-D; RESONATE X4 CRT-D; Suture Sleeve; VIGILIANT CRT-D; VIGILIANT X4 CRT-D

Manufacturer; Specification Developer; Complaint File Establishment

implantable pulse generator, pacemaker (non-crt) - ACCOLADE MRI; ESSENTIO MRI; FORMIO MRI; INGENIO MRI; INGEVITY MRI; PROPONENT MRI; Stylet; Suture Sleeve; VITALIO MRI

Manufacturer

Boston Scientific Corporation

PR/USA

2648729

2026

implantable pulse generator, pacemaker (non-crt) - ACUITY Spiral; ACUITY X4 Flushing Tool/Wire Guide; ACUITY X4 Spiral; ACUITY X4 Straight; AUTOGEN CRT-D; AUTOGEN X4 CRT-D; Bi Directional Torque Wrench; CONTAK CD Software Application; CONTAK CD2 Software Application; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D; INCEPTA CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; Lead Cap; MOMENTUM CRT-D; MOMENTUM X4 CRT-D; PUNCTUA CRT-D; RESONATE CRT-D; RESONATE HF CRT-D; RESONATE X4 CRT-D; Suture Sleeve; VIGILIANT CRT-D; VIGILIANT X4 CRT-D

Manufacturer

implantable pulse generator, pacemaker (non-crt) - ACCOLADE MRI; ESSENTIO MRI; FORMIO MRI; INGENIO MRI; INGEVITY MRI; PROPONENT MRI; Stylet; Suture Sleeve; VITALIO MRI

Manufacturer

Boston Scientific Limited

IRELAND

9616693

2026

implantable pulse generator, pacemaker (non-crt) - ACUITY Spiral; ACUITY X4 Flushing Tool/Wire Guide; ACUITY X4 Spiral; ACUITY X4 Straight; AUTOGEN CRT-D; AUTOGEN X4 CRT-D; Bi Directional Torque Wrench; CONTAK CD Software Application; CONTAK CD2 Software Application; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D; INCEPTA CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; Lead Cap; MOMENTUM CRT-D; MOMENTUM X4 CRT-D; PUNCTUA CRT-D; RESONATE CRT-D; RESONATE HF CRT-D; RESONATE X4 CRT-D; Suture Sleeve; VIGILIANT CRT-D; VIGILIANT X4 CRT-D

Manufacturer

implantable pulse generator, pacemaker (non-crt) - ACCOLADE; ADVANTIO; ALTRUA 2; ALTRUA 20; ALTRUA 40; ALTRUA 60; ESSENTIO; FORMIO; INGENIO; PROPONENT; Screw Cap Wrench; VITALIO

Manufacturer

implantable pulse generator, pacemaker (non-crt) - ACCOLADE MRI; ESSENTIO MRI; FORMIO MRI; INGENIO MRI; INGEVITY MRI; PROPONENT MRI; Stylet; Suture Sleeve; VITALIO MRI

Manufacturer

implantable pulse generator, pacemaker (non-crt) - AUTOGEN EL; DYNAGEN EL; DYNAGEN MINI; ENERGEN; INCEPTA; INOGEN EL; INOGEN MINI; MOMENTUM EL ICD; PERCIVA HF ICD; PERCIVA ICD; PUNCTUA; RESONATE EL ICD; RESONATE HF ICD; VIGILIANT EL ICD

Manufacturer

Isomedix Operations, Inc.

IL/USA

1450662

2026

implantable pulse generator, pacemaker (non-crt)

Contract Sterilizer

Medtronic Distribution Center

TN/USA

3009380063

2026

implantable pulse generator, pacemaker (non-crt) - Adapta; Adapta L; Adapta S; Advisa DR; Advisa DR MRI SureScan; Advisa SR MRI SureScan; Attesta DR MRI; Attesta L DR MRI; Attesta S DR MRI; Attesta SR MRI; Azure S DR MRI; Azure S SR MRI; Azure XT DR MRI; Azure XT SR MRI; CareLink SmartSync Azure Astra Application; InCheck Patient Assistant; Relia IPG; Sensia DR IPG; Sensia IPG; Sphera DR MRI; Sphera L DR MRI; Sphera SR MRI; Versa DR IPG

Repackager/Relabeler

implantable pulse generator, pacemaker (non-crt) - Adapter Cable; Analyzer Adapter; Analyzer Cable; CapSure Lead; CapSure VDD-2 Lead; CardioSight Reader; CareLink Encore Programmer; CareLink Encore Programmer RF Head; CareLink Express Mobile System - Android; CareLink Express Mobile System - iOS; CareLink Express Monitor; CareLink Programmer RF Head; CareLink SmartSync Base 24970A; CareLink SmartSync Common Application iOS; CareLink SmartSync Patient Connector 24967; CareLink SmartSync Power Cord 249705; CareLink SmartSync Power Supply 249701; CareLink SmartSync PSA Application; CareLink Wireless Network Adapter Card; ECG Cable; ECG Output Adapter; ECG Port Plug; Instrument Command Library (ICL)Device Command Library (DCL); Integrated Diagnostics Data Calculation Module Model 5242; Lead Analyzer; Medtronic CareLink Monitor; Medtronic CareLink Programmer; MyCareLink Patient Monitor; Prodigy IPG; Program Interface Cable; Service Kit; Sterile Plastic Sleeve

Repackager/Relabeler

implantable pulse generator, pacemaker (non-crt) - Attain; Attain Bipolar OTW Lead; Attain OTW; CareLink SmartSync Percepta, Solera, Serena Application; Consulta CRT-P; Insync; Percepta CRT-P MRI SureScan; Percepta Quad CRT-P MRI SureScan; Serena CRT-P MRI SureScan; Serena Quad CRT-P MRI SureScan; Solara CRT-P MRI SureScan; Solara Quad CRT-P MRI SureScan; Syncra CRT-P; Viva CRT-P

Repackager/Relabeler

implantable pulse generator, pacemaker (non-crt) - CapSureFix MRI SureScan Lead; Revo MRI SureScan

Repackager/Relabeler

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Establishment Registration & Device Listing

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