VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
FDA premarket approval P960040/S509 · decided 2025-09-16
Approval details
- PMA number
- P960040
- Supplement
- S509
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-09-02
- Decision date
- 2025-09-16
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- addition of alternate supplier Xylem Co for feedthrough pin components
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