BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S001 · Decision Sep 5, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
    PMA Number
    P960058
    Supplement Number
    S001
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 1997
    Date Received
    July 10, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the S-Series(TM) Speech Processor.