BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S396 · Decision Aug 30, 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
    PMA Number
    P960009
    Supplement Number
    S396
    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
    August 30, 2021
    Date Received
    January 25, 2021
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hardness grade and purged and cleaned between production batches of different hardness.

    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