BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S007 · Decision Jan 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM
    PMA Number
    P980040
    Supplement Number
    S007
    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
    January 4, 2007
    Date Received
    September 30, 2005
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MARKET MODEL AR40XEM INTRAOCULAR LENS (IOL) UNDER THE TECNIS TRADE NAME AND FOR THE FOLLOWING LABELING CLAIMS: 1) IMPROVED MESOPIC CONTRAST SENSITIVITY; 2) IMPROVED MESOPIC LOW-CONTRAST ACUITY; AND 3) REDUCED SPHERICAL ABERRATION.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens