BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980040 · Supplement: S048 · Decision Jul 24, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECNIS OPTIBLUE 1-PIECE IOL
    PMA Number
    P980040
    Supplement Number
    S048
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 24, 2014
    Date Received
    June 13, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., IN ANASCO, PUERTO RICO.