BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S008 · Decision Jan 19, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
    PMA Number
    P960058
    Supplement Number
    S008
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 19, 1999
    Date Received
    October 27, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older.