BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Essential Tremor

    PMA: P150031 · Supplement: S040 · Decision Oct 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Essential Tremor
    Trade Name
    Vercise PC, Vercise Gevia and Vercise Genus DBS Systems
    PMA Number
    P150031
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    PJS
    Generic Name
    Stimulator, electrical, implanted, for essential tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 20, 2021
    Date Received
    March 2, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to expand the current IFU to include: "Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM). The device is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability."

    Classifications

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

    Product Code Device Name
    PJS Stimulator, Electrical, Implanted, For Essential Tremor