BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P020018 · Supplement: S037 · Decision Jun 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ZENITH FLEX AAA ENDOVASCULAR GRAFT
    PMA Number
    P020018
    Supplement Number
    S037
    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
    June 7, 2011
    Date Received
    August 30, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD THE ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG TO THE EXISTING ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZENITH SPIRAL-Z AAA ENDOVASCULAR GRAFT ILIAC LEG AND IS INDICATED FOR USE WITH THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS, INCLUDING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU ANCILLARY GRAFT, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT, OR ZENITH BRANCH ILIAC ENDOVASCULAR GRAFT, DURING EITHER A PRIMARY OR SECONDARY PROCEDURE IN PATIENTS WHO HAVE ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS. THE GRAFT IS USED IN COMBINATION WITH THESE PRODUCTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS.

    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