BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P020004 · Supplement: S039 · Decision Mar 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    GORE EXCLUDER AAA ENDOPROSTHESIS
    PMA Number
    P020004
    Supplement Number
    S039
    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 5, 2009
    Date Received
    November 3, 2008
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE 31 MM GORE EXCLUDERENDOPROSTHESIS. THE 31 MM GORE EXCLUDERS ENDOPROSTHESIS INCLUDES TWO COMPONENTSTHAT WERE NOT INCLUDED IN PRIOR SUBMISSIONS: THE 31 MM TRUNK-IPSILATERAL LEG AND THE 32MM AORTIC EXTENDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GOREEXCLUDERS AAA ENDOPROSTHESIS AND IS INTENDED TO EXCLUDE THE ANEURYSM FROM BLOODCIRCULATION IN PATIENTS WHO HAVE APPROPRIATE ANATOMY AS FOLLOWS:1) ADEQUATE ILIAC/FEMORAL ACCESS;2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-29 MM AND A MINIMUM AORTICNECK LENGTH OF 15 MM; 3) PROXIMAL AORTIC NECK ANGULATION LESS THAN OR EQUAL TO 60 DEGREES; AND 4) ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8-18.5 MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 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