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

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    PMA: P130008 · Supplement: S135 · Decision Feb 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Hypoglossal Nerve, Implanted, Apnea
    Trade Name
    Model 3028 Connector Block Laser Weld Inspection Update
    PMA Number
    P130008
    Supplement Number
    S135
    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
    February 23, 2026
    Date Received
    January 27, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Model 3028 IPG header laser weld visual inspection

    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