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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTALENT ABDOMINAL STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP070027
Supplement NumberS011
Date Received08/10/2009
Decision Date02/04/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product 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 StudyShow Report Schedule and Study Progress
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