CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
FDA premarket approval P910023/S023 · decided 1997-04-17
Approval details
- PMA number
- P910023
- Supplement
- S023
- 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
- 1996-10-04
- Decision date
- 1997-04-17
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A NEW VERSION OF PROGRAMMER SOFTWARE FOR THE VENTRITEX(R) PROGRAMMER PR-1500. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRS V4.2H AND IS INDICATED FOR USE WITH PROGRAMMER PR-1500 AND CADENCE PULSE GENERATOR MODELS V-105, V-115 AND CONTOUR PULSE GENERATOR MODELS V-135, V-145.
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