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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSetPoint System
Generic NameVagus nerve stimulator for rheumatoid arthritis
ApplicantSetPoint Medical
25101 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP240039
Supplement NumberS002
Date Received09/26/2025
Decision Date02/18/2026
Product Code SFJ 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The firm requested approval to implement two supplier changes to the implant component of the SetPoint System for the printed circuit board assembly and the battery. Based upon the information submitted, the PMA supplement is approved.
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