VENTAK
FDA premarket approval P830060/S075 · decided 2013-08-07
Approval details
- PMA number
- P830060
- Supplement
- S075
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-05-16
- Decision date
- 2013-08-07
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES.
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