MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS
FDA premarket approval P980016/S025 · decided 2002-01-18
Approval details
- PMA number
- P980016
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-12-18
- Decision date
- 2002-01-18
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE CONNECTOR ASSEMBLY FOR THE GEM DR MODEL 7271, GEN II DR MODEL 7273 AND GEM III DR MODEL 7275.
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