BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100021 · Supplement: S011 · Decision Apr 27, 2012
    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 STENT GRAFT SYSTEM
    PMA Number
    P100021
    Supplement Number
    S011
    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 27, 2012
    Date Received
    November 2, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFIED VERSION OF THE ENDURANT STENT GRAFT SYSTEM. THE ENDURANT II STENT GRAFT SYSTEM IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING ADEQUATE ILIAC/FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; PROXIMAL NECK LENGTH OF => 10 MM: INFRARENAL NECK ANGULATION OF =< 60°; DISTAL FIXATION LENGTH OF => 15 MM; AORTIC NECK DIAMETERS WITH A RANGE OF 19-32 MM; ILIAC DIAMETERS WITH A RANGE OF 8-25 MM AND 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