Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (
FDA premarket approval P150012/S170 · decided 2025-09-22
Approval details
- PMA number
- P150012
- Supplement
- S170
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-08-26
- Decision date
- 2025-09-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to update device testing software and make a supplier-related wafer subcomponent change
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