CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
FDA premarket approval P910023/S013 · decided 1996-05-13
Approval details
- PMA number
- P910023
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1995-07-31
- Decision date
- 1996-05-13
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS AND USE OF EASY-TO-RETRIEVE BIOLOGICAL INDICATORS
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