PMA approvals

SetPoint System

SetPoint Medical · Vagus nerve stimulator for rheumatoid arthritis · Neurology

P240039 S004SupplementOK30
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PMA number
P240039
Supplement number
S004
Applicant
SetPoint Medical
Street 1
25101 Rye Canyon Loop
City
Valencia
State
CA
Zip
91355
Generic name
Vagus nerve stimulator for rheumatoid arthritis
Trade name
SetPoint System
Product code
SFJ
Advisory committee
NE
Advisory committee description
Neurology
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-29
Decision date
2026-10-29
Decision code
OK30
Ao statement
Approval for reducing endotoxin monitoring from every lot to quarterly, sampling at least one lot manufactured each quarter
Harmonized identifiers (openFDA)
Device name
Vagus Nerve Stimulator For Rheumatoid Arthritis
Medical specialty description
Unknown
Device class
3
Registration number
3011235999, 3009183442, 3013688988
FEI number
3011235999, 3009183442, 3013688988
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.