Data / Medical devices / Netherlands / Medtronic Bakken Research Center B.V. (BRC)
Medtronic Bakken Research Center B.V. (BRC): FDA-registered device maker in Maastricht Limburg, Netherlands, 1 PMA approval
Medtronic Bakken Research Center B.V. (BRC) is registered with the FDA (registration 3003276151) in Maastricht Limburg, Netherlands. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated December 9, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003276151
- Address
- Endepolsdomein 5, Maastricht Limburg, Netherlands, 6229 GW
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- March 12, 2008
- Registered through
- 2026
- Brand names listed
- Adaptor Extender Kit, Adaptor Kit, DF-1 Port Pin Plug, IS-1 Port Pin Plug Kit, Sprint Quattro Lead, Sprint Quattro MRI SureScan Lead, Sprint Quattro Secure Lead, Sprint Quattro Secure MRI SureScan Lead and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | 3 | Manufacturer | accessdata.fda.gov |
| Permanent Defibrillator Electrodes | NVY | 3 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 9, 1993 | P920015 | MEDTRONIC(R) TRANSVENE LEAD SYSTEM | NVY | 294 | August 19, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Permanent Defibrillator Electrodes
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
Updated August 19, 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.