MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
FDA premarket approval P900061/S029 · decided 1997-03-07
Approval details
- PMA number
- P900061
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1996-11-18
- Decision date
- 1997-03-07
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR JEWEL(R) MODELS 7219 B/D/E, 7202 D/E, 7220 B/D/E, 7221 B/CX/D/E MICROJEWEL(TM), AND 7223 MICRO JEWEL II(TM) WITH ENDOTAK(R) DSP LEAD MODELS 0092, 0093, 0094, 0096, 0097, 0123, AND 0125 AND THE MODEL 6836 Y CONNECTOR.
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