JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
FDA premarket approval P900061/S010 · decided 1995-04-27
Approval details
- PMA number
- P900061
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-04-11
- Decision date
- 1995-04-27
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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