CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S033 · decided 1998-10-21
Approval details
- PMA number
- P910023
- Supplement
- S033
- 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
- 1998-05-22
- Decision date
- 1998-10-21
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval of the Ventritex(R) Contour(R) MD Models V-175, V-175B, V-175C, V-175D and V-175AC and the Angstrom(TM) MD Models v-190F and V-190HV3.
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