BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100021 · Supplement: S021 · Decision Apr 16, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ENDURANT II AUI STENT GRAFT SYSTEM
    PMA Number
    P100021
    Supplement Number
    S021
    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
    April 16, 2013
    Date Received
    October 11, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM, A LINE EXTENSION TO THE CURRENT ENDURANT II STENT GRAFT SYSTEM. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME ENDURANT II STENT GRAFT SYSTEM. THE ENDURANT II BIFURCATED STENTGRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS. THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT IS INDICATED FOR THE ENDOVASCULARTREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF A BIFURCATED STENT GRAFT. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR USE IN PATIENTS WITH THE FOLLOWING CHARACTERISTICS:1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; 2) PROXIMAL NECK LENGTH OF ¿ 10MM; 3)INFRARENAL NECK ANGULATION OF ¿ 60°; 4) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32MM; 5) DISTAL FIXATION LENGTH(S) OF ¿ 15 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25MM; AND 7) MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR.

    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