JEWEL(TM) MODELS 7219 B/D/E, 7202 B/D/E JEWEL PLUS 7220 B/D/E
FDA premarket approval P900061/S013 · decided 1996-04-15
Approval details
- PMA number
- P900061
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- JEWEL(TM) MODELS 7219 B/D/E, 7202 B/D/E JEWEL PLUS 7220 B/D/E
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-06-26
- Decision date
- 1996-04-15
- Days to decision
- 294 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODEL 7219 B/D/E JEWEL(TM), MODEL 7202 D/E/ JEWEL(TM), MODEL 7220 B/D/E JEWEL PLUS DEVICE WITH ENDOTAK SERIES LEADS
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