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

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S406 · Decision Sep 1, 2021
    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
    S406
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 1, 2021
    Date Received
    August 3, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Equipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40); 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes.

    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