BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P020004 · Decision Nov 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    EXCLUDER BIFURCATED ENDOPROSTHESIS
    PMA Number
    P020004
    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
    November 6, 2002
    Date Received
    January 23, 2002
    Expedited Review
    N
    Docket Number
    02M-0527

    Advisory Committee Statement

    APPROVAL FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS. THE EXCLUDER BIFURCATED ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED: 1) ADEQUATE ILIAC/FEMORAL ACCESS 2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-26 MM AND A MINIMUM AORTIC NECK LENGTH OF 15 MM 3) PROXIMAL AORTIC NECK ANGULATION <= 60 DEGREES 4) ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8-13.5 MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM. THE AORTIC AND ILIAC EXTENDER ENDOPROSTHESES ARE INTENDED TO BE USED AFTER DEPLOYMENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS. THESE EXTENSIONS ARE INTENDED TO BE USED WHEN ADDITIONAL LENGTH AND/OR SEALING FOR ANEURISMAL EXCLUSION IS DESIRED.

    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