GEM MODEL 7227 CX/B/D/E
FDA premarket approval P900061/S053 · decided 2003-02-21
Approval details
- PMA number
- P900061
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM MODEL 7227 CX/B/D/E
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.