L110 ESSENTIO MRI SR,L111 ESSENTIO MRI DR,L131 ESSENTIO MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A
FDA premarket approval P150012/S172 · decided 2025-10-22
Approval details
- PMA number
- P150012
- Supplement
- S172
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- L110 ESSENTIO MRI SR,L111 ESSENTIO MRI DR,L131 ESSENTIO MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-09-30
- Decision date
- 2025-10-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.