FDA Registration
Active
🇨🇭 Switzerland
Medtronic Europe Sarl
Reg #: 9614453
·
FEI: 3002807576
·
Expires 2026
Products
14
Proprietary Names
170
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- Medtronic Europe Sarl
- Registration Number
- 9614453
- FEI Number
- 3002807576
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROUTE DU MOLLIAU 31, Case Postale
- City
- TOLOCHENAZ Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K212008
- PMA Number
- P010031
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2002-11-22 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2002-11-22 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2002-11-22 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2002-11-22 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2002-11-22 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2002-11-22 |
| Leadless Pacemaker | PNJ | Class 3 | Cardiovascular | No | 2016-04-07 |
| Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | MXD | Class 2 | Cardiovascular | No | 2021-07-22 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2015-05-29 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2007-01-24 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-01-24 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2007-01-24 |
| Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | OJX | Class 3 | Unknown | No | 2007-01-23 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2007-11-29 |
Proprietary Names
Viva Quad S CRT-D
Claria MRI Quad CRT-D
Amplia MRI CRT-D SureScan
Concerto II CRT-D
Viva S CRT-D
Consulta ICD
Brava
Viva
Maximo II CRT-D
Protecta XT CRT-D
Brava Quadripolar CRT-D
Viva Quad XT CRT-D
Protecta CRT-D
Consulta DF4 ICD
Compia MRI Quad CRT-D SureScan
Compia MRI CRT-D SureScan
Viva XT CRT-D
Amplia MRI Quad CRT-D SureScan
Concerto ICD
Claria MRI CRT-D
Crome HF CRT-D MRI SureScan
Crome HF Quad CRT-D MRI SureScan
Cobalt XT HF Quad CRT-D MRI SureScan
Cobalt HF Quad CRT-D MRI SureScan
Cobalt XT HF CRT-D MRI SureScan
Cobalt HF CRT-D MRI SureScan
Micra Transcatheter Pacemaker System
Micra TPS
Micra AV TPS
Micra AV2 TPS
Micra VR2 TPS
Transvene Lead
Reveal LINQ
Patient Assistant
REVEAL LINQ
Advisa DR MRI SureScan
Advisa DR
Adapta
InCheck Patient Assistant
Relia IPG
Adapta L
Adapta S
Advisa SR MRI SureScan
Versa DR IPG
Sensia DR IPG
Azure XT DR MRI
Azure S SR MRI
Azure XT SR MRI
Azure S DR MRI
CareLink SmartSync Azure Astra Application
Sphera DR MRI
Attesta L DR MRI
Attesta SR MRI
Attesta S DR MRI
Attesta DR MRI
Sphera SR MRI
Sphera L DR MRI
Sensia IPG
Analyzer Adapter
Prodigy IPG
Medtronic CareLink Monitor
Service Kit
Adapter Cable
Sterile Plastic Sleeve
CapSure Lead
CareLink Express Mobile System - Android
CapSure VDD-2 Lead
CareLink Express Monitor
ECG Port Plug
ECG Output Adapter
CareLink Wireless Network Adapter Card
Program Interface Cable
CareLink Express Mobile System - iOS
CareLink Encore Programmer
Analyzer Cable
ECG Cable
Lead Analyzer
MyCareLink Patient Monitor
CardioSight Reader
CareLink Encore Programmer RF Head
CareLink Programmer RF Head
Medtronic CareLink Programmer
CareLink SmartSync Power Cord 249705
CareLink SmartSync Patient Connector 24967
CareLink SmartSync Base 24970A
CareLink SmartSync PSA Application
CareLink SmartSync Common Application iOS
CareLink SmartSync Power Supply 249701
Integrated Diagnostics Data Calculation Module Model 5242
Instrument Command Library (ICL)Device Command Library (DCL)
Reveal DX
Reveal XT
Reveal LINQ Insertion Tools
CapSureFix MRI SureScan Lead
Revo MRI SureScan
Syncra CRT-P
Attain
Viva CRT-P
Solara CRT-P MRI SureScan
Percepta CRT-P MRI SureScan
Solara Quad CRT-P MRI SureScan
Insync
Attain Bipolar OTW Lead
Consulta CRT-P
Percepta Quad CRT-P MRI SureScan
Attain OTW
Serena CRT-P MRI SureScan
Serena Quad CRT-P MRI SureScan
CareLink SmartSync Percepta, Solera, Serena Application
PCD
End Cap
GEM
Patient Cable
Lead Patch
MICRO JEWEL
Patient Magnet
MICRO JEWEL II
Ace Header Emulator
Epicardial Patch Lead
Upsizing Sleeve
Sizing Sleeve
GEM VR
CareLink Network Software
Protecta VR
Marquis VR ICD
Visia AF MRI VR SureScan
Evera XT VR
Protecta DR
Visia AF MRI S VR SureScan
Virtuoso II DR/VR ICD
Maximo II DR
Visia AF VR
Evera MRI S VR
Evera XT DR
Evera MRI XT DR SureScan
Maximo VR ICD
Evera S DR
Evera MRI S DR SureScan
Marquis DR ICD
Evera S VR
Secura DR
Protecta XT VR
Protecta XT DR
Intrinsic ICD
Evera MRI XT VR SureScan
EnTrust ICD
Secura VR
Evera
Medtronic Longevity
Maximo II VR
Maximo DR ICD
Primo MRI VR SureScan
Primo MRI DR SureScan
Cobalt XT DR MRI Surescan
Cobalt VR MRI Surescan
Cobalt DR MRI Surescan
Crome DR MRI Surescan
Crome VR MRI Surescan
Cobalt XT VR MRI Surescan
Vitatron C20 SR IPG
CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025
Epsila EV MRI SureScan extravascular lead
Aurora EV-ICD MRI SureScan extravascular implantable cardioverter defibrillator
Epsila EV Sternal Tunneling Tool
AURORA EV-ICD MRI SURESCAN SW041
Epsila EV Transverse Tunneling Tool
Reveal XT Patient Assistant
Reveal XT ICM
Reveal Patient Assistant
Reveal DX ICM
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device