- Device
- L110 ESSENTIO™ MRI SR, L111 ESSENTIO™ MRI DR, L131 ESSENTIO™ MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT,
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S121
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-12-23
- Decision code
- OK30
- Date received
- 2021-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Re-order the low voltage pulse generator Top Attach/Test manufacturing process steps.