BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P140009 · Supplement: S124 · Decision Nov 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Deep Brain Stimulation (DBS) Neurostimulation System
    PMA Number
    P140009
    Supplement Number
    S124
    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
    November 7, 2025
    Date Received
    August 11, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    for following changes related to the Patient Magnet, which is an external medical device accessory. 1) Design Modifications: Magnet shape, Magnet Enclosure, Foam, Keeper covers and Keeper sheet (from stainless steel coated with epoxy to carbon steel)2) Material Update: Raw Magnet material change from Alloy of Aluminum-Nickel-Cobalt to Neodymium; Addition of Magnet Enclosures and Keeper covers made of Sabic Cycoloy HC1204HF, Polycarbonate (PC) and Acrylonitrile-butadiene-styrene (ABS) blend. 3) Suppliers Change: • Current Suppliers: o Raw magnet and keeper sheet – Hangzhou Yang Yi Magnetics Co., Ltd. o Magnet and Keeper assembly: Specialty Coating System • New Suppliers: o Raw magnet and keeper sheet – Dongguan Jiada Magnet Co., Ltd o Foam: AJR Enterprises o Magnet, Magnet Enclosure and Keeper assembly: Eptam Precision Molding.

    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