BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P990020 · Supplement: S009 · Decision Nov 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
    PMA Number
    P990020
    Supplement Number
    S009
    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 21, 2002
    Date Received
    June 3, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE XPEDIENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANEURX STENT GRAFT WITH EXPEDIENT DELIVERY SYSTEM AND IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING: 1) INFRARENAL, NON-ANEURYSMAL, NECK LENGTH OF GREATER THAN 1 CM AT THE PROXIMAL AND DISTAL ENDS OF THE ANEURYSM AND AN INNER VESSEL DIAMETER APPROXIMATELY 10-20% SMALLER THAN THE LABELED DEVICE DIAMETER: 2) MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR; 3) ONE OF THE FOLLOWING: A) ANEURYSM DIAMETER > 5 CM; B) ANEURYSM DIAMETER OF 4-5 CM WHICH HAS ALSO INCREASED IN SIZE BY 0.5 CM IN THE LAST 6 MONTHS; OR C) ANEURYSM WHICH IS TWICE THE DIAMETER OF THE NORMAL INFRARENAL AORTA.

    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