BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P190015 · Decision May 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    TREO® Abdominal Stent-Graft System
    PMA Number
    P190015
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 4, 2020
    Date Received
    June 3, 2019
    Expedited Review
    N
    Docket Number
    20M-1311

    Advisory Committee Statement

    Approval for TREO® Abdominal Stent-Graft System. This device is indicated for use in the endovascular treatment of patients with infrarenal abdominal aortic and aorto-iliac aneurysms with the following characteristics:1. Adequate iliac or femoral access compatible with the required delivery systems and accessories;2. Proximal aortic landing zone with: 2a. Infrarenal landing neck length of >= 15mm; 2b. Aortic neck diameters >= 17 mm and <= 32 mm; 2c. Suprarenal neck angle of <= 45 degrees; 2d. Infrarenal neck angle of <= 60 degrees. 3. Distal iliac landing zone with: 3a. an inside diameter of 8 mm – 13 mm and a length of >= 10 mm; or 3b. an inside diameter of > 13 mm – 20 mm and a length of >= 15 mm.4. Minimum overall AAA treatment length (proximal landing location to distal landing location) of 13 cm; and5. Minimum overall length from the lowest renal artery to the aortic bifurcation of 9 cm.

    Classifications

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

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment