BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P990080 · Supplement: S001 · Decision Oct 16, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
    PMA Number
    P990080
    Supplement Number
    S001
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 16, 2001
    Date Received
    September 5, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW FOLDABLE, ULTRAVIOLET LIGHT-ABSORBING, POSTERIOR CHAMBER INTRAOCULAR LENS MODEL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL Z9000 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.