BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S385 · Decision Jun 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Percept and Activa Deep Brain Stimulation Therapy Systems
    PMA Number
    P960009
    Supplement Number
    S385
    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 9, 2021
    Date Received
    September 4, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) the Pain PC System for Spinal Cord Stimulation (SCS) which includes Implantable Neurostimulation Systems Vanta with AdaptiveStim and Sequentia LT; and 2) modified labeling for the Model B31060 Connector Plug to reflect its intended use with the Pain PC system.3) labeling updates for previously approved devices to be consistent with Pain PC system labeling.

    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