BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P200030 · Decision Dec 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    Gore Excluder Conformable AAA Endoprosthesis (CEXC)
    PMA Number
    P200030
    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
    December 22, 2020
    Date Received
    June 29, 2020
    Expedited Review
    N
    Docket Number
    20M-2339

    Advisory Committee Statement

    Approval for Gore Excluder Conformable AAA Endoprosthesis (EXCC)This device is indicated to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below:1) Adequate iliac / femoral access;2) Infrarenal aortic neck treatment diameter range of 16–32 mm;3) A minimum aortic neck length of 15 mm when proximal aortic neck angulation is =<60 degrees; and4) Iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 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