BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940022 · Supplement: S002 · Decision Jan 10, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2
    PMA Number
    P940022
    Supplement Number
    S002
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 10, 1997
    Date Received
    November 15, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE ELECTRODE COUPLING, REFERRED TO AS "ENHANCED BIPOLAR."