BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S065 · Decision Apr 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
    PMA Number
    P810031
    Supplement Number
    S065
    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
    April 29, 2019
    Date Received
    December 3, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Healon GV® PRO, a modification of the Healon5 PRO OVD with the sodium hyaluronate concentration changed from 23 mg/mL to 18 mg/mL. The device, as modified, will be marketed under the trade name Sodium Hyaluronate Ophthalmic Viscoelastc Device (OVD), Healon GV® PRO and is indicated for use in anterior segment ophthalmic surgical procedures of the human eye. The Healon GV® PRO OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The Healon GV® PRO OVD can also be used to efficiently separate and control ocular issues. The Healon GV® PRO OVD is not designed to have any pharmacological effect.

    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