BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P150031 · Supplement: S039 · Decision Nov 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
    Trade Name
    Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems
    PMA Number
    P150031
    Supplement Number
    S039
    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
    November 15, 2021
    Date Received
    January 29, 2021
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to add alternate suppliers for the patient contacting components of the SureTek Burr Hole Cover Kits, used during the deep brain stimulation (DBS) process, for the Vercise, Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems

    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