BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S024 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    HEALON SODIUM HYALURONATE
    PMA Number
    P810031
    Supplement Number
    S024
    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
    July 25, 2002
    Date Received
    July 10, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE "PRECAUTION" SECTION OF THE PACKAGE INSERT TO INCLUDE THE FOLLOWING: "BEFORE INITIATING PHACOEMULSIFICA-TION, USE IRRIGATION/ ASPIRATION TO CREATE A FLUID-FILLED SPACE ABOVE THE LENS. THIS REDUCES THE RISK OF INITIAL VISCO-OCCULSION OF THE PHACO TIP OR THE IRRIGATION LINE WHICH COULD CAUSE PHACO TIP HEATING."

    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