BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    PMA: P130008 · Supplement: S002 · Decision Feb 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Stimulator, Hypoglossal Nerve, Implanted, Apnea
    Trade Name
    INSPIRE II UPPER AIRWAY STIMULATOR
    PMA Number
    P130008
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MNQ
    Generic Name
    Stimulator, hypoglossal nerve, implanted, apnea
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 2015
    Date Received
    June 30, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATE TO THE TABLET HARDWARE AND OPERATING SYSTEM OF THE MODEL 2740 PHYSICIAN PROGRAMMER, AND RELATED CHANGES TO THE MODEL 2740 PROGRAMMER MANUAL.

    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