CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500
FDA premarket approval P910023/S012 · decided 1995-12-22
Approval details
- PMA number
- P910023
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 1995-06-30
- Decision date
- 1995-12-22
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM WITH "C" AND "D" HEADER STYLES FOR CADET V-105 AND V-115, AND PROGRAMMER MODEL PR-1500 SOFTWARE VERSION 4.1
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