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

    Stimulator, Thalamic, Epilepsy, Implanted

    PMA: P960009 · Supplement: S437 · Decision Sep 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13

    Basic Information

    Device Name
    Stimulator, Thalamic, Epilepsy, Implanted
    Trade Name
    Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
    PMA Number
    P960009
    Supplement Number
    S437
    Device Class
    FDA Class 3
    Product Code
    MBX
    Generic Name
    Stimulator, thalamic, epilepsy, implanted
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 7, 2022
    Date Received
    August 10, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Repositioning of equipment (and cleanroom) within the existing manufacturing facility of a critical supplier to Medtronic that manufactured fabricated metal components.

    Classifications

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

    Product Code Device Name
    MBX Stimulator, Thalamic, Epilepsy, Implanted