VENTAK P2
FDA premarket approval P930035/S016 · decided 2006-05-12
Approval details
- PMA number
- P930035
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK P2
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-04-13
- Decision date
- 2006-05-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO THE BIOBURDEN SAMPLING PLAN.
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