BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P910056 · Supplement: S036 · Decision Jul 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    enVista One Piece Hydrophobic Acrylic Intraocular Lens
    PMA Number
    P910056
    Supplement Number
    S036
    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
    July 2, 2019
    Date Received
    April 3, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the enVista® One Piece Hydrophobic Acrylic IOL, Model MX60ET, which includes a modification to the intraocular lens (IOL) material formulation of the approved parent lens, enVista® Model MX60T.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens