BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Iris

    PMA: P170039 · Supplement: S002 · Decision Oct 3, 2019
    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
    Supplement Number
    S002
    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
    October 3, 2019
    Date Received
    July 19, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) protocol.

    Classifications

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

    Product Code Device Name
    QBT Artificial Iris