FDA.reportPublic FDA data

PMA P240039

Device
SetPoint System
Applicant
SetPoint Medical
Product code
SFJ
Decision date
2026-02-18
Generic name
Vagus nerve stimulator for rheumatoid arthritis
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.

Current openFDA PMA Record#

Device
SetPoint System
Applicant
SetPoint Medical
PMA number
P240039
Supplement
S002
Product code
SFJ
Generic name
Vagus nerve stimulator for rheumatoid arthritis
Decision date
2026-02-18
Decision code
APPR
Date received
2025-09-26
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.