BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P020018 · Supplement: S064 · Decision May 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    Zenith® Iliac Branch
    PMA Number
    P020018
    Supplement Number
    S064
    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
    May 30, 2025
    Date Received
    August 1, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Zenith Iliac Branch. The Zenith Iliac Branch, when used with the necessary additional components (Zenith AAA devices and a covered bridging stent), is indicated for endovascular treatment of aortoiliac or iliac aneurysms to preserve internal iliac arterial blood flow when the distal sealing site in the common iliac artery is insufficient for the AAA device alone and when the vessel morphology is suitable for repair: 1) Common iliac artery diameter at the level of the internal iliac artery (luminal diameter) ?16 mm; 2) Adequate iliac/femoral access compatible with a 20 French (7.7mm O.D.) introduction system; 3) Non-aneurysmal external iliac artery fixation segment distal to the aneurysm: with a length of at least 20mm and with a diameter measured outer wall to outer wall of no greater than 11mm and no less than 8mm; 4) Non-aneurysmal internal iliac artery segment distal to the aneurysm: with a length of at least 10mm (with 20-30mm being preferred) and with a diameter measured outer wall to outer wall no greater than 10mm and no less than 7mm

    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