PMA P960040S512
- Device
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S512
- Product code
- LWS
- Decision date
- 2026-04-01
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
Current openFDA PMA Record#
- Device
- VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S512
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-01
- Decision code
- OK30
- Date received
- 2026-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier