BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S029 · Decision Apr 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR
    PMA Number
    P000025
    Supplement Number
    S029
    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 8, 2008
    Date Received
    October 25, 2007
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE OPUS 2 SPEECH PROCESSOR AS AN ADDITIONAL EXTERNAL BEHIND-THE-EAR SPEECH PROCESSOR FOR USE WITH THE COMBI 40+ COCHLEAR IMPLANT SYSTEM.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear