INGEVITY+ Active Fixation
FDA premarket approval P150012/S167 · decided 2025-04-16
Approval details
- PMA number
- P150012
- Supplement
- S167
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY+ Active Fixation
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-03-19
- Decision date
- 2025-04-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- the addition of a second source supplier of the rear seal components for INGEVITY leads
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