BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P990020 · Decision Sep 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ANEURX STENT GRAFT SYSTEM
    PMA Number
    P990020
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 28, 1999
    Date Received
    April 12, 1999
    Expedited Review
    Y
    Docket Number
    99M-4331

    Advisory Committee Statement

    This device is indicated for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm, and a vessel diameter 10-20% smaller than labeled device diameter; 3) Morphology suitable for endovascular repair; and 4) One of the following: A diameter > 5cm; A diameter of 4-5cm and has increased in size by 0.5cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta.

    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