BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Neuromuscular, Implanted

    PMA: P950035 · Supplement: S001 · Decision Mar 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Neuromuscular, Implanted
    Trade Name
    NEUROCONTROL FREEHAND SYSTEM(R)
    PMA Number
    P950035
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    GZC
    Generic Name
    Stimulator, neuromuscular, implanted
    Regulation Number
    882.5860
    Medical Specialty
    Neurology
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 20, 1998
    Date Received
    February 10, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the supplier of the Platinum-Iridium (Pt-Ir) electrode discs used in the manufacture of the Freehand Epimysial Electrodes and a change in the Model Numbering for the Freehand System.

    Classifications

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

    Product Code Device Name
    GZC Stimulator, Neuromuscular, Implanted