GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR
FDA premarket approval P900061/S041 · decided 2000-03-02
Approval details
- PMA number
- P900061
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-12-17
- Decision date
- 2000-03-02
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for modifications to the circuitry of the Medtronic Model 7227 GEM Implantable Cardioverter Defibrillator.
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