BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Extended Depth Of Focus Intraocular Lens

    PMA: P980040 · Supplement: S161 · Decision Dec 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Extended Depth Of Focus Intraocular Lens
    Trade Name
    TECNIS Symfony™ Extended Range Of Vision Intraocular Lens
    PMA Number
    P980040
    Supplement Number
    S161
    Device Class
    FDA Class 3
    Product Code
    POE
    Generic Name
    Extended depth of focus intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 2023
    Date Received
    July 3, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    approval of modifications to the final professional and patient labeling for the TECNIS Symfony™ Extended Range Of Vision Intraocular Lens (Models ZXR00 and ZXT 150-600) to include the results of your postmarket study.

    Classifications

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

    Product Code Device Name
    POE Extended Depth Of Focus Intraocular Lens