BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    PMA: P150031 · Supplement: S046 · Decision Nov 10, 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 Genus™ Deep Brain Stimulation (DBS) System
    PMA Number
    P150031
    Supplement Number
    S046
    Device Class
    FDA Class 3
    Product Code
    NHL
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian symptoms
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 10, 2021
    Date Received
    October 12, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Use VLSIP Technologies as an alternate supplier for the Ball Grid Array (BGA), an electronic component on the Printed Circuit Board Assembly (PCBA) of the Implantable Pulse Generators (IPG) and External Trial Stimulators (ETS) of the WaveWriter Alpha Spinal Cord Stimulator (SCS) System and Vercise Genus Deep Brain Stimulation (DBS) System.

    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