BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Vagus Nerve Stimulator For Rheumatoid Arthritis

    PMA: P240039 · Supplement: S002 · Decision Feb 18, 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
    S002
    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
    February 18, 2026
    Date Received
    September 26, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee 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.

    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