SetPoint System
FDA premarket approval P240039 · decided 2025-07-30
Approval details
- PMA number
- P240039
- Trade name
- SetPoint System
- Generic name
- Vagus nerve stimulator for rheumatoid arthritis
- Applicant
- SetPoint Medical
- Date received
- 2024-11-04
- Decision date
- 2025-07-30
- Days to decision
- 268 days
- Decision code
- APPR
- Product code
- SFJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- The SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs).
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