BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P810031 · Supplement: S056 · Decision Jun 14, 2016
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI
    PMA Number
    P810031
    Supplement Number
    S056
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 14, 2016
    Date Received
    December 17, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an alternative secondary blister tray packaging configuration called drop pack for AMOs family of Healon® OVDs that incorporates a transition Tyvek® lid manufactured using DuPonts flash-spinning process.