BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P810031 · Supplement: S069 · Decision Dec 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya
    PMA Number
    P810031
    Supplement Number
    S069
    Device Class
    FDA Class 3
    Product Code
    LZP
    Generic Name
    AID, SURGICAL, VISCOELASTIC
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 16, 2020
    Date Received
    November 27, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the emulsion used for pretreatment of glass cylinders for Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVDs), including Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon Duet® PRO Dual Pack OVDs.

    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