BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S004 · Decision May 28, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
    PMA Number
    P960058
    Supplement Number
    S004
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 28, 1998
    Date Received
    March 30, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the CIM 3.