BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Neuromuscular, Implanted

    PMA: P950035 · Supplement: S007 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Neuromuscular, Implanted
    Trade Name
    NEUROCONTROL FREEHAND SYSTEM
    PMA Number
    P950035
    Supplement Number
    S007
    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
    June 23, 2000
    Date Received
    March 14, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE DISTRIBUTION OF AN IMPLANT TESTER ACCESSORY WHICH IS USED IN FINAL DEVICE TESTING AT THE COMPLETION OF SURGERY.

    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