Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

Medtronic Europe Sarl

SWITZERLAND

9614453

2026

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer; Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Brava; Brava Quadripolar CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D

Manufacturer; Repackager/Relabeler

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

PR/USA

2649622

2026

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer; Repackager/Relabeler

MEDTRONIC SOFAMOR DANEK USA, INC.

TN/USA

3003120897

2026

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Brava; Brava Quadripolar CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D

Manufacturer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer

MEDTRONIC VASCULAR

MA/USA

1220452

2026

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer

MEDTRONIC, INC.

MN/USA

2182208

2026

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer; Repackager/Relabeler; Specification Developer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - 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

Manufacturer; Specification Developer

pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) - Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Brava; Brava Quadripolar CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D

Manufacturer; Specification Developer

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Establishment Registration & Device Listing

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