BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000015 · Supplement: S005 · Decision Aug 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI)
    PMA Number
    P000015
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 22, 2003
    Date Received
    June 24, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A POLYTEREPHTHALATE (PET) MESH DISK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT WITH PET MESH DISK AND IS INTENDED TO RESTORE USEFUL HEARING IN INDIVIDUALS WITH NEUROFIBROMATOSIS TYPE 2 (NF2) WHO ARE 12 YEARS OF AGE OR OLDER, VIA ELECTRICAL STIMULATION OF THE COCHLEAR NUCLEUS.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear