BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P910056 · Supplement: S019 · Decision Nov 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ENVISTA HYDROPHOBIC INTRAOCULAR LENS
    PMA Number
    P910056
    Supplement Number
    S019
    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
    November 19, 2015
    Date Received
    March 25, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE COMPONENT SUPPLIER FOR THE ACRYLIC SHEET USED TO MILL ENVISTA® HYDROPHOBIC INTRAOCULAR LENS BUTTONS (MODEL MX60). SPECIFICALLY, THE SHEET MANUFACTURING PROCESS IS TO ALTERNATIVELY TRANSFER TO THE BAUSCH AND LOMB FACILITY IN WILMINGTON, MASSACHUSETTS (WIL).

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens