PMA supplement
N970003 S303: L100 ESSENTIO™ SR,L101 ESSENTIO™ DR,L121 ESSENTIO™ EL DR,L200 PROPONENT™ SR,L201 PROPONENT™ DR,L221 PROPONENT™ EL DR,L30
FDA PMA supplement · 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | N970003 |
|---|---|
| Supplement number | S303 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | L100 ESSENTIO™ SR,L101 ESSENTIO™ DR,L121 ESSENTIO™ EL DR,L200 PROPONENT™ SR,L201 PROPONENT™ DR,L221 PROPONENT™ EL DR,L30 |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Boston Scientific Corp |
| Product code | LWP |
| Received date | Sep 30, 2025 |
| Decision date | Oct 22, 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: