VENTAK AV ICD
FDA premarket approval P960040/S164 · decided 2008-04-17
Approval details
- PMA number
- P960040
- Supplement
- S164
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK AV ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-03-12
- Decision date
- 2008-04-17
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR AN UPDATED HEADER CONFIGURATION FOR THE CONFIENT AND LIVIAN DEVICE FAMILIES TO INCLUDE CHANGED SETSCREWS, SEAL PLUGS, AND LEFT VENTRICULAR RING LEAD WIRE ROUTING (LIVIAN ONLY) AS WELL AS THE ADDITION OF A NEW MODEL TORQUE WRENCH.
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