BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S097 · Decision Feb 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE LOADED DELIVERY SYSTEM MODELS
    PMA Number
    P930014
    Supplement Number
    S097
    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 14, 2017
    Date Received
    November 16, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the edits to the physician labeling for the AcrySof® IQ Toric IOL with the UltraSert™ Pre-Loaded Delivery System, Models AU00T3, AU00T4, AU00T5, AU00T6, AU00T7, AU00T8, AU00T9.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens