Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems
FDA premarket approval P830060/S082 · decided 2018-04-25
Approval details
- PMA number
- P830060
- Supplement
- S082
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-03-26
- Decision date
- 2018-04-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Updates to the BET test method.
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