BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P080004 · Supplement: S043 · Decision Dec 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
    PMA Number
    P080004
    Supplement Number
    S043
    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
    December 28, 2021
    Date Received
    October 4, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for nine (9) changes to the routine Ethylene Oxide (EO) sterilization process, including:1) The sterilization equipment used in your routine EO sterilization process;2) the implementation of a unified set of EO sterilization process parameters for your US marketed products;3) the lower control limit for EO gas used in your routine EO sterilization process;4) the method for monitoring EO gas concentration;5) the frequency of EO sterilant residuals testing; 6) the Process Challenge Device (PCD) used during routine EO sterilization cycles and validation activities;7) the number of PCDs used during routine EO sterilization cycles and validation activities;8) the approach used for validation/re-validation activities; and9) the re-validation cycle.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens