BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P840024 · Supplement: S068 · Decision Apr 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
    PMA Number
    P840024
    Supplement Number
    S068
    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
    April 4, 1997
    Date Received
    December 9, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MARKETING OF THE AUDALLION BEAM FORMING PRE-PROCESSOR AND FOR APPROVAL OF DEVICE EFFECTIVENESS CLAIMS FOR THE AUDALLIN AS USED WIT THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (SPEAK SPEECH PROCESSOR). THE AUDALLION IS INDICATED FOR USE BY ADULTS WHO ARE USING THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM TO AID THEM IN IMPROVING SPEECH UNDERSTADNING IN NOISY ENVIRONMENTS WHEN THE SPEECH AND THE NOISE ARE NOT COMING FROM THE SAME DIRECTION

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear