- Device
- ESSENTIO™ MRI (Models L110, L111, L131) PROPONENT™ MRI (Models L210, L211, L231) ACCOLADE™ MRI (Models L310, L311, L331)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S173
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-12-19
- Decision code
- APPR
- Date received
- 2025-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Software Maintenance Release 6 (SMR6) package of software updates for the ACCOLADE family of pacemakers and CRT-Ps