JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
FDA premarket approval P900061/S008 · decided 1995-08-22
Approval details
- PMA number
- P900061
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1994-10-18
- Decision date
- 1995-08-22
- Days to decision
- 308 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MEDTRONIC, INC., MED-REL, ROAD 909, KM. 0.4., BARRIO MARIANA, HUMACAO, PUERTO RICO, TO MANUFACTURE THE MODEL 7219D JEWEL PCD AND THE MODEL 7202D JEWEL CD
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