VENTAK FAMILY OF IMPLANTABLE CARIOVERTER DEFIBRILLATOR
FDA premarket approval P960040/S094 · decided 2006-01-13
Approval details
- PMA number
- P960040
- Supplement
- S094
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK FAMILY OF IMPLANTABLE CARIOVERTER DEFIBRILLATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-12-16
- Decision date
- 2006-01-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- RECEIVING SPEAKERS WITH POLYMIDE TAPE APPLIED AND THE LEADS TRIMMED TO LENGTH BY THE SPEAKER MANUFACTURER, KNOWLES ELECTRONICS, INC.
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