Data / Medical devices / Switzerland / Medtronic Europe Sarl
Medtronic Europe Sarl: FDA-registered device maker in TOLOCHENAZ Vaud, Switzerland, 7 510(k) clearances and 11 PMA approvals
Medtronic Europe Sarl is registered with the FDA (registration 9614453) in TOLOCHENAZ Vaud, Switzerland. It lists 14 device types. The FDA files 7 510(k) clearances and 11 PMA approvals under its listings, the newest dated October 20, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9614453
- FEI number
- 3002807576
- Address
- ROUTE DU MOLLIAU 31 Case Postale, TOLOCHENAZ Vaud, Switzerland, 1131
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 2, 2002
- Registered through
- 2027
- Brand names listed
- AURORA EV-ICD MRI SURESCAN SW041, Ace Header Emulator, Adapta, Adapta L, Adapta S, Adapter Cable, Advisa DR, Advisa DR MRI SureScan and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2021 | K212008 | Reveal LINQ Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 23, 2017 | K162855 | Reveal LINQ | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 22, 2016 | K160689 | Reveal LINQ | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 27, 2015 | K150117 | Medtronic Patient Asistant | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 14, 2014 | K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 4, 2011 | K103764 | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 21, 2007 | K071655 | REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 20, 2023 | P220012 | Aurora EV-ICD System | LWS | 75 | July 31, 2026 | accessdata.fda.gov |
| April 6, 2016 | P150033 | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM | PNJ | 225 | September 8, 2026 | accessdata.fda.gov |
| February 8, 2011 | P090013 | REVO MRI SURESCAN IPG AND PACING SYSTEM | LWP | 325 | June 5, 2025 | accessdata.fda.gov |
| June 26, 2002 | P010031 | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | NIK | 902 | October 5, 2026 | accessdata.fda.gov |
| August 28, 2001 | P010015 | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM | LWP | 574 | October 23, 2026 | accessdata.fda.gov |
| June 14, 2000 | P980050 | MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF | LWS | 142 | April 15, 2026 | accessdata.fda.gov |
| September 27, 1999 | P990001 | DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2 | NVZ | 119 | March 20, 2025 | accessdata.fda.gov |
| January 29, 1999 | P980035 | MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE | NVZ | 822 | October 23, 2026 | accessdata.fda.gov |
| October 9, 1998 | P980016 | VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS | LWS | 933 | October 5, 2026 | accessdata.fda.gov |
| February 11, 1993 | P900061 | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM | LWS | 170 | April 15, 2026 | accessdata.fda.gov |
| August 24, 1989 | P890003 | SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 | NVZ | 459 | July 31, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Implantable Pulse Generator, Pacemaker (Non-Crt)
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- All makers of Pacemaker/Icd/Crt Non-Implanted Components
- All makers of Pulse Generator, Permanent, Implantable
- All makers of Programmer, Pacemaker
- All makers of Implantable Pacemaker Pulse-Generator
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.