BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940022 · Supplement: S008 · Decision Feb 19, 1999
    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
    S008
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 19, 1999
    Date Received
    September 3, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium.