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

    PMA: P080010 · Supplement: S017 · Decision Jan 15, 2019
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECNIS 3-Poece Multifocal
    PMA Number
    P080010
    Supplement Number
    S017
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 15, 2019
    Date Received
    December 21, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changing an in-process sampling procedure for buttons used to manufacture 1-piece and 3-piece IOLs.