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

    PMA: P080010 · Supplement: S015 · Decision May 9, 2018
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Tecnis 3-piece Multifocal
    PMA Number
    P080010
    Supplement Number
    S015
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 9, 2018
    Date Received
    April 11, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Sterilization of the intraocular lens products manufactured at the Johnson & Johnson Vision Care manufacturing facility in Puerto Rico using vessel #4 and hot cell #5.