BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Iris

    PMA: P170039 · Supplement: S003 · Decision Sep 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Artificial Iris
    Trade Name
    CustomFlex ArtificialIris
    PMA Number
    P170039
    Supplement Number
    S003
    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
    September 4, 2020
    Date Received
    September 25, 2019
    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 the addition of a second supplier of saline solution used for filling the artificial iris primary packaging.

    Classifications

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

    Product Code Device Name
    QBT Artificial Iris