- Device
- Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S461
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new X-ray System to the battery manufacturing process.