CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
FDA premarket approval P910023/S015 · decided 1997-03-03
Approval details
- PMA number
- P910023
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-03-21
- Decision date
- 1997-03-03
- Days to decision
- 347 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR VENTRITEX(R) HOUSECALL(TM) SYSTEM WITH TRANSMITTER MODEL TR 2400 (SOFTWARE VERSION 1.1) AND RECEIVER MODEL RE 2400 (SOFTWARE VERSION 1.0)
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