- Device
- ESSENTIO™ MRI SR SL (L110); ESSENTIO™ MRI DR SL (L111); ESSENTIO™ MRI DR EL (L131); PROPONENT™ MRI SR SL (L210); PROPONE
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S189
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-07-23
- Decision code
- OK30
- Date received
- 2026-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components