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

    PMA: P980040 · Supplement: S053 · Decision Nov 15, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
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    Basic Information

    Trade Name
    SENSAR 1-PIECE LENS MODEL AAB00
    PMA Number
    P980040
    Supplement Number
    S053
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 15, 2014
    Date Received
    October 20, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE FROM MACHINED TO A MOLDED IOL EDGE BLOCKER, CHANGE IN CYCLE TIME FOR THE IOL TUMBLING PROCESS, ADDITION OF A COSMETIC INSPECTION FOLLOWINGSTERILIZATION, CHANGE IN TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF IOLS, ANDNEW ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY EQUIPMENT FOR TESTING RESIDUAL MONOMER LEVELS OF IOL SOFT ACRYLIC MATERIAL.