ESSENTIO MRI (Models L110, L111, L131) PROPONENT MRI (Models L210, L211, L231) ACCOLADE MRI (Models L310, L311, L331)
FDA premarket approval P150012/S173 · decided 2025-12-19
Approval details
- PMA number
- P150012
- Supplement
- S173
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESSENTIO MRI (Models L110, L111, L131) PROPONENT MRI (Models L210, L211, L231) ACCOLADE MRI (Models L310, L311, L331)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-11-19
- Decision date
- 2025-12-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for the Software Maintenance Release 6 (SMR6) package of software updates for the ACCOLADE family of pacemakers and CRT-Ps
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