CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S037 · decided 1998-12-09
Approval details
- PMA number
- P910023
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1998-11-23
- Decision date
- 1998-12-09
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval to use alternate silicone materials in the manufacture of Ventritex implantable defibrillators.
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