BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S361 · Decision Jun 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    (MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems
    PMA Number
    P960009
    Supplement Number
    S361
    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
    June 24, 2020
    Date Received
    October 18, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following:1) Model B35200 Percept PC Implantable Neurostimulator (INS);2) Model B31060 Connector Plug;3) Updates to the Model A610 Clinician Programmer Application (PPA) Software to version 2.0;4) Updates to the Model A620 Patient Programmer Application (CPA) to version 2.0;5) Updates to the Model 8880T2 Communicator (clinician telemetry device) firmware; 6) New Model TH91 Handset and Communicator kit; and7) Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept PC System.

    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