BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S050 · Decision Jul 22, 2011
    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
    S050
    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, 2011
    Date Received
    December 27, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATED VERSION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANTSYSTEM REFERRED TO AS MAESTRO 2010 CONSISTING OF THE FOLLOWING FEATURES: 1) A THINNER VERSION OF THE SONATATI- 100 COCHLEAR IMPLANT, THE MI1000 MED-EL CONCERT;2) SEVERAL DESIGN AND MANUFACTURING UPDATES RELATED TO THE INTRODUCTION OF THE MI1000 MEDEL CONCERT; 3) NEW TASKS AND FUNCTIONALITIES ADDED TO THE MAESTRO FITTING SOFTWARE IN MAESTRO 4.0; 4) A SELECTION OF NEW COLORS AVAILABLE FOR THE OPUS 2 AUDIO PROCESSOR AND; 5) A NEW, MORE ENERGY-EFFICIENT, AUDIO PROCESSOR COIL CALLED D-COIL.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear