- Device
- L110 ESSENTIO™ MRI SR,L111 ESSENTIO™ MRI DR,L131 ESSENTIO™ MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S172
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-10-22
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies