ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33
FDA premarket approval P150012/S168 · decided 2025-07-11
Approval details
- PMA number
- P150012
- Supplement
- S168
- 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, L33
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-05-20
- Decision date
- 2025-07-11
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for Software Maintenance Release (SMR) 5 for the ACCOLADE family of pacemakers and CRT-Ps and the associated Model 3869 Brady programmer software application on the Model 3300 LATITUDE Programming System
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.