BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P960058 · Supplement: S028 · Decision Nov 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
    PMA Number
    P960058
    Supplement Number
    S028
    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
    November 25, 2002
    Date Received
    November 1, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR CHANGES TO THE HIFOCUS ELECTRODE TO BETTER FACILITATE THE PACKING OF THE COCHLEOSTOMY AND ELECTRODE INSERTION. SPECIFICALLY, THE CHANGES ARE TO MOVE THE OFFSET REGION APPROXIMATELY 3 MM FURTHER AWAY FROM THE CURRENT LOCATION.

    Classifications

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

    Product Code Device Name
    MCM Implant, Cochlear