BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S002 · Decision Jun 22, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
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    Basic Information

    Trade Name
    CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
    PMA Number
    P960058
    Supplement Number
    S002
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 22, 1998
    Date Received
    November 25, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Postmarket Language study. A postapproval languate study consisting of 20 to 30 children under age 6 will be undertaken using the Reynell Development Language Scales revised (RDLS). Data will be collected for 3 years at 6-month intervals.The data analysis will include a statistical analysis of effectiveness data -- both the subset of speech intelligibility measures used during the postapproval study as described in amendment#11, dated June 20, 1997, and the Reynell test of expressive and receptive ability.Results of the long-term data must be reflected in the labeling, via a PMA supplement, when the postapproval study is completed.