BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P060011 · Supplement: S008 · Decision Sep 9, 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
    S008
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 9, 2015
    Date Received
    August 13, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE BLISTER TRAY AND FOIL LID MATERIAL SPECIFICATION.