BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Auditory Brainstem

    PMA: P000015 · Supplement: S016 · Decision Jun 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Implant, Auditory Brainstem
    Trade Name
    NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM
    PMA Number
    P000015
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MHE
    Generic Name
    Implant, auditory brainstem
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 13, 2017
    Date Received
    October 12, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new CochlearTM CP1000 Nucleus N7 Sound Processor, which is an external component of the Nucleus 24 Cochlear Implant System, the Nucleus Hybrid L24 Implant System, and the Nucleus Auditory Brainstem Implant System.

    Classifications

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

    Product Code Device Name
    MHE Implant, Auditory Brainstem