BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S474 · Decision Jul 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
    PMA Number
    P960009
    Supplement Number
    S474
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 1, 2024
    Date Received
    February 28, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    which requested approval for the following changes for each supplement:For P960009/S474 for:• The removal of the contraindication: “Implantation of a deep brain stimulation system is contraindicated for patients for whom test stimulation is unsuccessful and the addition of a precaution that specifies two conditions under which full system implantation can occur (i.e., successful test stimulation, or confirmation of lead implantation to the targeted site via imaging.)• An update to MRI labeling to allow additional active scan time for scans below specified B1+rms limits.For H020007/S364 and H050003/S317 for:• An update to MRI labeling to allow additional active scan time for scans below specified B1+rms limits.

    Classifications

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

    Product Code Device Name
    MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor