MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974
FDA premarket approval P980050/S024 · decided 2006-09-13
Approval details
- PMA number
- P980050
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2006-06-12
- Decision date
- 2006-09-13
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE POST APPROVAL STUDY TO UPDATE THE RESPECT STUDY PROTOCOL AND RELATED DOCUMENTATION TO INCORPORATE THE ENRHYTHM DEVICE (MODEL P15001DR), THE ENRHYTHM SOFTWARE (MODEL 9987), AND THE INCHECK PATIENT ASSISTANT (MODEL 2696).
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