- Device
- PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S090
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-03-05
- Decision code
- OK30
- Date received
- 2020-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace particle size analyzer test equipment with functionally equivalent test equipment.