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

    PMA: P980040 · Supplement: S060 · Decision Apr 17, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL
    PMA Number
    P980040
    Supplement Number
    S060
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 17, 2015
    Date Received
    March 23, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATIVE MOLDING SUPPLIER FOR THE UPPER BODY COMPONENT OF THE TECNIS® PRELOADED DELIVERY SYSTEMS (MODELS PCB00, PMB00, PCT150, PCT225, PCT300, AND PCT400) AND AN ALTERNATIVE MOLD SUPPLIER FOR THE 1MTEC30 CARTRIDGE, LOWER BODY AND PROTECTOR CAP COMPONENTS.