BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940022 · Supplement: S004 · Decision Mar 17, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
    PMA Number
    P940022
    Supplement Number
    S004
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 1998
    Date Received
    December 23, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of a modified ICS lead electrode, i.e., the Flex Lead Electrode.