PMA supplement
P150012 S168: ESSENTIO™ MRI (Models L110, L111, L131); PROPONENT™ MRI (Models L210, L211, L231); ACCOLADE™ MRI (Models L310, L311, L33
FDA PMA supplement · Real-Time Process · Boston Scientific
Key facts
| Original PMA | P150012 |
|---|---|
| Supplement number | S168 |
| Supplement type | Real-Time Process |
| Reason for the supplement | 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 |
| Product code | LWP |
| Received date | May 20, 2025 |
| Decision date | Jul 11, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: