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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSetPoint System
Generic NameVagus nerve stimulator for rheumatoid arthritis
ApplicantSetPoint Medical
25101 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP240039
Date Received11/04/2024
Decision Date07/30/2025
Product Code SFJ 
Docket Number 25M-2963
Notice Date 08/06/2025
Advisory Committee Neurology
Clinical TrialsNCT04539964
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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