BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P110007 · Supplement: S009 · Decision Oct 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585
    PMA Number
    P110007
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 31, 2017
    Date Received
    November 14, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Lifecore Biomedical, LLC, 1245 Lakeview Drive Chaska, Minnesota to be used for post-sterilization final packaging,warehousing, and distribution activities.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZP Aid, Surgical, Viscoelastic