GEM III DR 7275, GEM III VR 7231, GEM DR 7271
FDA premarket approval P980016/S030 · decided 2003-02-21
Approval details
- PMA number
- P980016
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM III DR 7275, GEM III VR 7231, GEM DR 7271
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-12-03
- Decision date
- 2003-02-21
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MOVE OF THE EOC MANUFACTURING OPERATIONS IN KERKRADE, THE NETHERLANDS TO EOC, MEDTRONIC B.V., HEERLEN, THE NETHERLANDS.
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