INGEVITY + Leads - Active Fixation
FDA premarket approval P150012/S158 · decided 2024-09-16
Approval details
- PMA number
- P150012
- Supplement
- S158
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INGEVITY + Leads - Active Fixation
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2024-04-22
- Decision date
- 2024-09-16
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for expanding the Indications for Use of the INGEVITY+ pacing leads to include placement and pacing in the left bundle branch area as an alternative to standard right ventricular pacing
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.