BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Vagus Nerve Stimulator For Rheumatoid Arthritis

    PMA: P240039 · Supplement: S001 · Decision Jan 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Vagus Nerve Stimulator For Rheumatoid Arthritis
    Trade Name
    SetPoint System
    PMA Number
    P240039
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    SFJ
    Generic Name
    Vagus nerve stimulator for rheumatoid arthritis
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 16, 2026
    Date Received
    August 27, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee 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).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SFJ Vagus Nerve Stimulator For Rheumatoid Arthritis