PMA
P240039: SetPoint System
FDA PMA · Vagus nerve stimulator for rheumatoid arthritis · SetPoint Medical
Key facts
| PMA number | P240039 |
|---|---|
| Trade name | SetPoint System |
| Generic name | Vagus nerve stimulator for rheumatoid arthritis |
| Applicant | SetPoint Medical |
| Owner/operator | SetPoint Medical |
| Product code | SFJ |
| Approval date | Jul 30, 2025 |
| Docket number | 25M-2963 |
| Notice date | Aug 6, 2025 |
| Establishment registration | 3013688988 |
| FEI number | 3013688988 |
At a glance
- 1–9 Supplements
- Feb 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: