BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P880090 · Supplement: S020 · Decision Jun 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
    PMA Number
    P880090
    Supplement Number
    S020
    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
    June 14, 2004
    Date Received
    March 18, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM. STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY. THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH & LOMB, INC., CLEARWATER, FLORIDA.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens