MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
FDA premarket approval P900061/S036 · decided 1999-12-02
Approval details
- PMA number
- P900061
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-03-08
- Decision date
- 1999-12-02
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Medtronic(R) Model 7227 GEM(TM) Implantable Cardioverter Defibrillator with Connector Configuration Modules 5227B, 5227D, and 5227E.
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