BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P120006 · Supplement: S031 · Decision Mar 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    Alto Abdominal Stent Graft System
    PMA Number
    P120006
    Supplement Number
    S031
    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
    March 13, 2020
    Date Received
    March 13, 2019
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    20M-1126

    Advisory Committee Statement

    Approval for the Alto Abdominal Stent Graft System. The device is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following:1) Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories;2) A proximal aortic landing zone for the sealing ring 7mm below the inferior renal artery; 3) An aortic sealing zone comprised of healthy aorta defined as; a. Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery; b. Lack of significant calcification at the level of 7mm below the inferior renal artery; c. Conicity < 10% as measured from the inferior renal artery to the aorta 7mm below the inferior renal artery; d. An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery; and e. An aortic angle of <= 60 degrees. 4) A distal iliac landing zone: a. With a length of at least 10 mm; and b. With an inner wall diameter of no less than 8 mm and no greater than 25 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