BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lens, Intraocular, Toric Optics

    PMA: P980040 · Supplement: S079 · Decision Mar 24, 2017
    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 IOL Model ZCT
    PMA Number
    P980040
    Supplement Number
    S079
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 24, 2017
    Date Received
    February 23, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of the AMO Kulim, Malaysia manufacturing site for the production of your TECNIS Toric IOL Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525, and ZCT600.

    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