MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276
FDA premarket approval P900061/S042 · decided 2001-05-25
Approval details
- PMA number
- P900061
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-02-05
- Decision date
- 2001-05-25
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN ALTERNATE FACILITY FOR THE MANUFACTURING, PACKAGING, AND STERILIZATION OF THE MODEL 7227CX, MODEL 7275, MODEL 7231, AND MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS LOCATED AT MEDTRONIC S.A., TOLOCHENAZ, SWITZERLAND.
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