BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P840039 · Supplement: S030 · Decision Feb 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TIER A UV-ABSORBING POSTERIOR CHAMBER INTARA. LENS
    PMA Number
    P840039
    Supplement Number
    S030
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 7, 1996
    Date Received
    August 19, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF D & C GREEN NO.6 DYE TO THE HAPTICS OF THE SINGLE-PIECE POLYMETHYLMETHACRYLATE (PMMA) IOLS UNDER THIS PMA AND MANUFACTURED FROM PMMA SUPPLIED FROM THE ST. LOUIS FACILITY

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQL Intraocular Lens