GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974
FDA premarket approval P980050/S016 · decided 2004-08-31
Approval details
- PMA number
- P980050
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2004-06-18
- Decision date
- 2004-08-31
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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