BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P090003 · Supplement: S005 · Decision Feb 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM
    PMA Number
    P090003
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 3, 2011
    Date Received
    July 6, 2010
    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 MULTIPLE COMPONENT-SPECIFIC MANUFACTURING PROCESS CHANGES. THE DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS FOUND IN ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE DIAMETER OF 6 MM TO 10 MM.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac