BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S011 · Decision Jul 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
    PMA Number
    P000025
    Supplement Number
    S011
    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
    July 22, 2003
    Date Received
    June 18, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR VERTICAL INTEGRATION OF THE COCHLEAR IMPLANT LASER WELDING PROCESS AT THE MANUFACTURING SITE LOCATED AT MED-EL MEDICAL ELECTRONICS, INNSBRUCK, AUSTRIA.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear