CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S044 · decided 1999-10-13
Approval details
- PMA number
- P910023
- Supplement
- S044
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-08-23
- Decision date
- 1999-10-13
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for an alternate manufacturing site for accessories and the DP-3238 Defibrillation Patch Lead located at St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342-3577.
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