PMA P240039S001

Device: SetPoint System
Applicant: SetPoint Medical
PMA number: P240039
Supplement: S001
Product code: SFJ
Decision date: 2026-01-16
Classification: Neurology
Generic name: Vagus nerve stimulator for rheumatoid arthritis
Approval order 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).

Current openFDA PMA Record#

Device: SetPoint System
Applicant: SetPoint Medical
PMA number: P240039
Supplement: S001
Product code: SFJ
Generic name: Vagus nerve stimulator for rheumatoid arthritis
Decision date: 2026-01-16
Decision code: APPR
Date received: 2025-08-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order 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).