Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste
FDA premarket approval P960040/S461 · decided 2020-12-11
Approval details
- PMA number
- P960040
- Supplement
- S461
- 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 Cardioverter Defibrillator Syste
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-12-10
- Decision date
- 2020-12-11
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add a new X-ray System to the battery manufacturing process.
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