BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S365 · Decision Jun 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Activia Deep Brain Stimulation Therapy System
    PMA Number
    P960009
    Supplement Number
    S365
    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 25, 2020
    Date Received
    December 2, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the new WR9200 Wireless Recharger Subsystem and associated labeling. The new WR9200 Wireless Recharger Subsystem is intended to recharge the Activa RC implantable neurostimulator (INS) for Deep Brain Stimulation Therapy and the following Restore INSs for Spinal Cord Stimulation Therapy: RestoreUltra; RestoreUltra SureScan MRI; RestoreSensor; and RestoreSensor SureScan MRI.

    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