BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P060011 · Supplement: S007 · Decision Oct 15, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES
    PMA Number
    P060011
    Supplement Number
    S007
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 15, 2015
    Date Received
    June 5, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE TUMBLING PROCESS.