CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S022 · decided 1996-11-08
Approval details
- PMA number
- P910023
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-08-02
- Decision date
- 1996-11-08
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CADET HIGH-VOLTAGE CAN ICD MODELS V-105AC AND V-115AC, CADET TEST CAN MODEL AC-CDT-TCN, CADET TEST CABLE MODEL AC-CDT-TCB, CONTOUR HIGH-VOLTAGE CAN ICD MODELS V-135AC AND V-145AC, CONTOUR TEST CAN MODEL AC-TCN AND CONTOUR TEST CABLE MODEL AC-TCB
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