BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Vagus Nerve Stimulator For Rheumatoid Arthritis

    PMA: P240039 · Decision Jul 30, 2025
    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
    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
    July 30, 2025
    Date Received
    November 4, 2024
    Expedited Review
    N
    Docket Number
    25M-2963

    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