BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P070027 · Decision Apr 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    THE TALENT ABDOMINAL STENT GRAFT SYSTEM
    PMA Number
    P070027
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    April 15, 2008
    Date Received
    October 18, 2007
    Expedited Review
    N
    Docket Number
    08M-0244

    Advisory Committee Statement

    APPROVAL FOR THE TALENT ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS WITH OR WITHOUT ILIAC INVOLVEMENT HAVING:1) ILIAC/FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES;2) A PROXIMAL AORTIC NECK LENGTH OF >= 10MM; 3) PROXIMAL AORTIC NECK ANGULATION <= 60?; 4) DISTAL ILIAC ARTERY FIXATION LENGTH OF >=15MM;5) AN AORTIC NECK DIAMETER OF 18-32MM AND ILIAC ARTERY DIAMETERS OF 8-22MM; AND 6) VESSEL MORPHOLOGY SUITABLE FOR ENDOVASCULAR 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