- Device
- Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S087
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-12-04
- Decision code
- OK30
- Date received
- 2019-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a post-reflow manufacturing inspection for printed circuit boards.