BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S023 · Decision Sep 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    COMBO 40+ COCHLEAR IMPLANT SYSTEM
    PMA Number
    P000025
    Supplement Number
    S023
    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
    September 24, 2007
    Date Received
    March 29, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE OPUS-1 EXTERNAL SPEECH PROCESSOR AND THE MAESTRO 2.0.1, WHICH ARE NEW COMPONENTS OF THE APPROVED COMBI 40+ COCHLEAR IMPLANT SYSTEM AND ARE INDICATED FOR USE ON PATIENTS WHO HAVE BEEN IMPLANTED WITH PULSARCI100 AND/OR SONATATI100 COCHLEAR IMPLANTS. THE SOFTWARE, MAESTRO 2.0.1, IS INTENDED FOR PROGRAMMING THE OPUS-1 SPEECH PROCESSOR, AND IMPLEMENTS TWO NEW SPEECH CODING STRATEGY FEATURES, HIGH DEFINITION CIS (HDCIS) AND FINE STRUCTURE PROCESSING (FSP).

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear