- Device
- ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S122
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternate nitrile gloves to be used in the manufacturing operations at BSC-Clonmel.