INGEVITY+ Active Fixation Pace/Sense Lead
FDA premarket approval P150012/S125 · decided 2022-08-29
Approval details
- PMA number
- P150012
- Supplement
- S125
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- INGEVITY+ Active Fixation Pace/Sense Lead
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-06-13
- Decision date
- 2022-08-29
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for updated clinical summary labeling for the INGEVITY+ leads.
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