BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    PMA: P250013 · Supplement: S001 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stimulator, Hypoglossal Nerve, Implanted, Apnea
    Trade Name
    aura6000™ system
    PMA Number
    P250013
    Supplement Number
    S001
    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
    April 30, 2026
    Date Received
    March 31, 2026
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the New Enrollment post-approval study (PAS) submitted to comply with the conditions of approval outlined in our approval order for P250013

    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