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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTHE TALENT ABDOMINAL STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP070027
Date Received10/18/2007
Decision Date04/15/2008
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 08M-0244
Notice Date 04/24/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 
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