BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Toric Optics

    PMA: P980040 · Supplement: S056 · Decision Mar 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Lens, Intraocular, Toric Optics
    Trade Name
    TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM
    PMA Number
    P980040
    Supplement Number
    S056
    Device Class
    FDA Class 3
    Product Code
    MJP
    Generic Name
    LENS, INTRAOCULAR, TORIC OPTICS
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 17, 2015
    Date Received
    December 24, 2014
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE PACKAGING OF THE MODEL SERIES ZCT INTRAOCULAR LENSES (IOL) FROM A WHEELCASE CONFIGURATION TO A PRELOADED PACKAGING CONFIGURATION/DELIVERY SYSTEM. THE PRELOADED LENS MODELS WILL BE BRANDED UNDER THE NAME ¿TECNIS® TORIC 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODELS PCT150, PCT225, PCT300 AND PCT400.¿

    Classifications

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

    Product Code Device Name
    MJP Lens, Intraocular, Toric Optics