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

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    PMA: P130008 · Supplement: S109 · Decision Apr 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Stimulator, Hypoglossal Nerve, Implanted, Apnea
    Trade Name
    Model 4063 Stimulation Lead and 4340 Sensing Lead
    PMA Number
    P130008
    Supplement Number
    S109
    Device Class
    FDA Class 3
    Product Code
    MNQ
    Generic Name
    Stimulator, hypoglossal nerve, implanted, apnea
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 24, 2024
    Date Received
    March 28, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    A change to the IS-1 connector manufacturing process of the Model 4063 Stimulation Lead and 4340 Sensing Lead to introduce a two-cavity mold and to change the method used to inspect IS-1 Critical To Quality (CTQ) dimensions.

    Classifications

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

    Product Code Device Name
    MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea