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

    PMA: P980040 · Supplement: S061 · Decision May 1, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SENSAR SOFT ACRYLIC INTRAOCULAR LENSES
    PMA Number
    P980040
    Supplement Number
    S061
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 1, 2015
    Date Received
    April 1, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A NEW METHOD FOR MEASUREMENT OF THE OPTICAL PROPERTIES(DIOPTER AND IMAGE QUALITY) OF THE 3-PIECE ACRYLIC AND SILICONE IOLS PRODUCED AT AMO¿S PUERTO RICO FACILITY.