BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S060 · Decision Mar 5, 2012
    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
    S060
    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
    March 5, 2012
    Date Received
    December 16, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE TOLERANCE LIMITS FOR THE OPUS 1 SPEECH PROCESSOR FREQUENCY MEASUREMENT DURING FINAL INSPECTION OF THE DEVICE. THE REASON FOR THE CHANGE IN THE TOLERANCE LIMITS WAS A CHANGE IN THE OPUS 1 MICROPHONE FROM THE ORIGINAL MICROPHONE KNOWLES EG-3000-CX TO THE KNOWLES EG-23000-CX.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear