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

    Intraocular Lens

    PMA: P080004 · Supplement: S040 · Decision May 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System
    PMA Number
    P080004
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 7, 2021
    Date Received
    April 12, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Removal of the ethylene oxide ink indicator on individual sterilization pouches of fully preloaded intraocular lens devices, and replacement with an ethylene oxide indicator sticker that will be attached to the sterilization tray during batch sterilization.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens