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

    Implant, Auditory Brainstem

    PMA: P000015 · Supplement: S042 · Decision Dec 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Implant, Auditory Brainstem
    Trade Name
    Nucleus ABI541 Auditory Brainstem Implant
    PMA Number
    P000015
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    MHE
    Generic Name
    Implant, auditory brainstem
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 13, 2019
    Date Received
    November 13, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing change of the silicone overmoulding used in the CI500 Series Cochlear Implant and the ABI541 Auditory Brainstem Implant.

    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