MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
FDA premarket approval P900061/S031 · decided 1997-03-13
Approval details
- PMA number
- P900061
- Supplement
- S031
- 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
- 1997-02-18
- Decision date
- 1997-03-13
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 6925 UPSIZING SLEEVE WHICH WILL ALLOW A 5.0 MM LEAD CONNECTOR TO FIT INTO A 6.5 MM CONNECTOR PORT OF A MEDTRONIC IMPLANTABLE DEFIBRILLATOR
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