VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES
FDA premarket approval P930035/S022 · decided 2012-10-05
Approval details
- PMA number
- P930035
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-07-26
- Decision date
- 2012-10-05
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
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