BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S039 · Decision Apr 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL COCHLEAR IMPLANT SYSTEMS
    PMA Number
    P000025
    Supplement Number
    S039
    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 30, 2009
    Date Received
    February 18, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES MADE TO THE FOLLOWING USER MANUALS: DIB II (DIAGNOSTIC INTERFACE BOX), OPUS 1, OPUS 2 AND TEMPO+ SPEECH PROCESSORS, RBP (REMOTE BATTERY PACK) AND MICROPHONE TEST DEVICE (MTD).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear