BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Auditory Brainstem

    PMA: P000015 · Supplement: S049 · Decision Apr 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Implant, Auditory Brainstem
    Trade Name
    Nucleus 24 Auditory Brainstem Implant System
    PMA Number
    P000015
    Supplement Number
    S049
    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
    April 24, 2023
    Date Received
    January 20, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the material and design of the coil crimp and its joining process used in the CI500 Series & CI600 Series Cochlear Implants 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