BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100021 · Decision Dec 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
    PMA Number
    P100021
    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
    December 16, 2010
    Date Received
    June 4, 2010
    Expedited Review
    N
    Docket Number
    11M-0040

    Advisory Committee Statement

    APPROVAL FOR THE ENDURANT STENT GRAFT SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS 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 <= 60 DEGREES; 4) DISTAL FIXATION LENGTH OF >= 15 MM; 5) AORTIC NECK DIAMETERS WITH A RANGE OF 19 TO 32 MM; 6) ILIAC DIAMETERS WITH A RANGE OF 8 TO 25 MM; 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