MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE
FDA premarket approval P900061/S027 · decided 1996-10-22
Approval details
- PMA number
- P900061
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Trade name
- MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1996-07-15
- Decision date
- 1996-10-22
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR EXTENDING THE SHELF LIFE TO 18 MONTHS FOR THE MODELS 7219 B/D/E, 7202 D/E JEWEL, 7220 B/C/D/E/ JEWEL PLUS AND 7221 B/C/CX/D/E/ MICROJEWEL(TM)
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