- Device
- PG Essentio MRI SR SL, PG Essentio MRI DR SL, PG Essentio MRI DR EL, PG Proponent MRI SR SL, PG Proponent MRI DR EL, PG
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S127
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-07-27
- Decision code
- OK30
- Date received
- 2022-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate surge suppressor due to a new second-tier supplier.