BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Neuromuscular, Implanted

    PMA: P950035 · Supplement: S009 · Decision Jan 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Neuromuscular, Implanted
    Trade Name
    NEUROCONTROL FREEHAND II SYSTEM
    PMA Number
    P950035
    Supplement Number
    S009
    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
    January 18, 2002
    Date Received
    December 22, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE UNIVERSAL EXTERNAL CONTROLLER (UEC), REVISED FREEHAND CLINICIAN PROGRAMMING INTERFACE SOFTWARE, VERSION 5.0, WHICH ARE USED TO OPERATE AND PROGRAM THE FREEHAND IMPLANTABLE-RECEIVER STIMULATOR, AND SUBSEQUENT CHANGES TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FREEHAND II 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