BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S038 · Decision Nov 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS
    PMA Number
    P810031
    Supplement Number
    S038
    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
    November 22, 2010
    Date Received
    September 3, 2010
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE TO UPDATE THE LABELING THAT WAS APPROVED UNDER PMA SUPPLEMENT P810031/S017 TO REFLECT THE ABBOTT BRANDING GUIDELINES.

    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