BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aid, Surgical, Viscoelastic

    PMA: P880031 · Supplement: S013 · Decision Nov 8, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Aid, Surgical, Viscoelastic
    Trade Name
    AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION
    PMA Number
    P880031
    Supplement Number
    S013
    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 8, 1999
    Date Received
    October 15, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to 1) extend the finished product UV absorbance specification from 0.012 AU to 0.016 AU and 2) eliminate the UV absorbance specification from the 24 month shelf-life.

    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