BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S005 · Decision Sep 4, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
    PMA Number
    P960058
    Supplement Number
    S005
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 4, 1998
    Date Received
    June 30, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following question and answer has been affixed to page 29: "Are there any restriction on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, such as using a protective helmet, to reduce the risk of device failure."