BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S020 · Decision May 31, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM
    PMA Number
    P000025
    Supplement Number
    S020
    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
    May 31, 2006
    Date Received
    April 17, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW DIAGNOSTIC INTERFACE BOX II (DIB II). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIB II AND IS INTENDED TO OFFER THE CLINICIAN TOOLS FOR DIFFERENT CLINICAL APPLICATIONS WITH THE MED-EL 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