PMA supplement
P240039 S001: SetPoint System
FDA PMA supplement · Normal 180 Day Track No User Fee · SetPoint Medical
Key facts
| Original PMA | P240039 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | SetPoint System |
| Generic name | Vagus nerve stimulator for rheumatoid arthritis |
| Applicant | SetPoint Medical |
| Product code | SFJ |
| Received date | Aug 27, 2025 |
| Decision date | Jan 16, 2026 |
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: