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

    PMA: P980040 · Supplement: S050 · Decision Oct 23, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P
    PMA Number
    P980040
    Supplement Number
    S050
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 23, 2014
    Date Received
    September 24, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD A NEW OIL-FREE COMPRESSED AIR (OFCA) SYSTEM AT THE AMO ANASCO, PUERTO RICO FACILITY.