BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100021 · Supplement: S063 · Decision Sep 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    Endurant II/IIs Stent Graft System
    PMA Number
    P100021
    Supplement Number
    S063
    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
    September 29, 2017
    Date Received
    April 3, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    17M-5997

    Advisory Committee Statement

    Approval for the expansion of the indications for use of the Endurant II/Endurant IIs Stent Graft System to include the treatment of infrarenal abdominal aortic aneurysms having neck lengths >= 4 mm and < 10 mm (“short necks”), when used in conjunction with the Heli-FX EndoAnchor System. The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (>= 4 mm and < 10 mm) infrarenal necks. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/Endurant IIs Stent Graft System is indicated for use in patients with the following characteristics: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) Proximal neck length of: >=10 mm or >= 4 and <10 mm, when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only) (Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter); 3) Infrarenal neck angulation of <= 60°; 4) Aortic neck diameters with a range of 19 to 32 mm; 5) Distal fixation length(s) of >= 15 mm; 6) Iliac diameters with a range of 8 to 25 mm; and 7) Morphology suitable for aneurysm repair.

    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