MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
FDA premarket approval P900061/S028 · decided 1996-08-06
Approval details
- PMA number
- P900061
- Supplement
- S028
- 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
- 1996-07-15
- Decision date
- 1996-08-06
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 7221B/CX/D/E/ MICRO JEWEL WITH ENDOTAK SERIES LEADS INLCUDING 60, 70 AND 110 SERIES LEADS (MODELS 0060, 0062, 0063, 0064, 0070, 0072, 0073, 0074, 0075, 0113, 0115) AND THE MODEL 6836 Y CONNECTOR
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