BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P150031 · Supplement: S089 · Decision Dec 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    Vercise Genus™ Deep Brain Stimulation (DBS) Systems
    PMA Number
    P150031
    Supplement Number
    S089
    Device Class
    FDA Class 3
    Product Code
    NHL
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian symptoms
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 10, 2025
    Date Received
    September 25, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the extension of shelf-life from 6 months to 15 months for the Hydrogen Silsesquioxane material utilized in the insulation layer production of a component within the printed circuit board assembly of Implantable Pulse Generator (IPG) and of External Trial Stimulator (ETS) Kits in the WaveWriter Alpha™ Prime Spinal Cord Stimulation and Vercise™ Genus Deep Brain Stimulation Systems. The component, manufactured by a third-party supplier, is not patient-contacting and is fully encapsulated within the IPG and ETS.

    Classifications

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

    Product Code Device Name
    NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms