MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
FDA premarket approval P900061/S034 · decided 1997-11-26
Approval details
- PMA number
- P900061
- Supplement
- S034
- 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
- 1997-11-17
- Decision date
- 1997-11-26
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of silicone gel over the internal surfaces of the Fast Recovery Diode in the Medtronic(R) Implantable Cardioverter Defibrillator Models 7219, 7220, 7221, and 7223.
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