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

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P140009 · Supplement: S080 · Decision Oct 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
    PMA Number
    P140009
    Supplement Number
    S080
    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
    October 28, 2022
    Date Received
    September 29, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implement two manufacturing changes used in the production of contact assemblies in supplier Bal Seal Engineering, Inc.’s production of contact assemblies, i.e., 1) to qualify alternate welding equipment used to process the spring component of contact assemblies; and 2) to implement visual automated optical inspection for performing the 100% inspection of the spring component's inner diameter.

    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