BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P150002 · Decision Nov 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    INCRAFT(R) AAA STENT GRAFT SYSTEM
    PMA Number
    P150002
    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
    November 27, 2018
    Date Received
    January 15, 2015
    Expedited Review
    N
    Docket Number
    18M-4580

    Advisory Committee Statement

    Approval for the endovascular treatment of patients with infrarenal abdominal aortic aneurysms with the following characteristics:1) Adequate, but complex iliac or femoral vessel morphology (e.g., high tortuosity index, heavily calcified, small diameter), that is compatible with vascular access techniques, devices or accessories;2) Proximal neck length >= 10 mm;3) Aortic neck diameters >=17 mm and <= 31 mm;4) Aortic neck suitable for suprarenal fixation;5) Infrarenal and suprarenal neck angulation <= 60°;6) Iliac fixation length >= 15 mm;7) Iliac diameters >= 7 mm and <= 22 mm; and 8) Minimum overall AAA treatment length (proximal landing location to distal landing location) >= 128 mm.

    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