BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S059 · Decision Dec 16, 2011
    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
    S059
    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
    December 16, 2011
    Date Received
    October 17, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE OPUS 2 BATTERY PACK XS WHICH IS AN ADDITIONAL OPTIONAL BATTERY PACK FOR USE WITH THE FOLLOWING APPROVED AUDIO PROCESSORS OF THE MED-EL COCHLEAR IMPLANT (CI) SYSTEM: TEMPO+, OPUS 1 AND OPUS 2.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear