BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S009 · Decision Mar 22, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
    PMA Number
    P960058
    Supplement Number
    S009
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 22, 1999
    Date Received
    February 4, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116.