|Trade Name||TALENT ABDOMINAL STENT GRAFT SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding the talent converter stent graft and talent occluder as line extensions to the already existing talent abdominal product family. The device, as modified, will be marketed under the trade name talent converter stent graft system with xcelerant hydro delivery system & talent occluder with occluder delivery system. The talent converter is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the talent or aneurx bifurcated stent grafts in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation. The talent occluder is indicated for endoluminal occlusion of the common iliac artery in order to prevent retrograde blood into the aneurysm sac when used in conjunction to a fem-fem bypass.
|Post-Approval Study||Show Report Schedule and Study Progress|