- Device
- ESSENTIO™ MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT™ MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S130
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-09-27
- Decision code
- OK30
- Date received
- 2022-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an automatic handling system for the helium leak test process.