BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Iris

    PMA: P170039 · Decision May 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Artificial Iris
    Trade Name
    CustomFlex Artificial Iris
    PMA Number
    P170039
    Device Class
    FDA Class 3
    Product Code
    QBT
    Generic Name
    Artificial iris
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 30, 2018
    Date Received
    November 29, 2017
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the CustomFlex Artificial Iris. The CustomFlex Artificial Iris is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.

    Classifications

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

    Product Code Device Name
    QBT Artificial Iris