BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960058 · Supplement: S010 · Decision Jul 16, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION DEVICE FITTING SOFTWARE (SCLIN)
    PMA Number
    P960058
    Supplement Number
    S010
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 16, 1999
    Date Received
    March 24, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.