VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES)
FDA premarket approval P960040/S078 · decided 2012-06-22
Approval details
- PMA number
- P960040
- Supplement
- S078
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Trade name
- VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-16
- Decision date
- 2012-06-22
- Days to decision
- 2502 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MINOR MANUFACTURE CHANGES OF THE DEVICES.
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