BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P960034 · Decision Aug 12, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.
    PMA Number
    P960034
    Advisory Committee
    Neurology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    August 12, 1998
    Date Received
    October 1, 1996
    Expedited Review
    N
    Docket Number
    98M-0725

    Advisory Committee Statement

    Approval for lens models with the heparin surface modification applied to all your single-piece PMMA lenses approved in P810055. These models will be specified with a "C" following the number designation for the corresponding non-HSM PMMA model. The lenses will be marketed under the trade name CeeOn(TM) HSM PMMA IOLs. This device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by an extracapsular cataract extraction (ECCE) or phacoemulsification. They are intended to be placed in the capsular bag.