PMA supplement
P150012 S109: ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR
FDA PMA supplement · 30-Day Notice · Boston Scientific
Key facts
| Original PMA | P150012 |
|---|---|
| Supplement number | S109 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific |
| Product code | LWP |
| Received date | Apr 26, 2021 |
| Decision date | Apr 30, 2021 |
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: