VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERSTER DEFIBRILLATOR (AICD) FAMILIES
FDA premarket approval P910077/S120 · decided 2012-04-23
Approval details
- PMA number
- P910077
- Supplement
- S120
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERSTER DEFIBRILLATOR (AICD) FAMILIES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-03-26
- Decision date
- 2012-04-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
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