JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
FDA premarket approval P900061/S011 · decided 1995-08-01
Approval details
- PMA number
- P900061
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-05-30
- Decision date
- 1995-08-01
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR TECOTHANE 75D POLYURETHANE RESIN IN MEDTRONIC IMMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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