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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 NameTALENT THORACIC STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP070007
Date Received03/01/2007
Decision Date06/05/2008
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 08M-0342
Notice Date 06/09/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the talent thoracic stent graft system. The device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal aortic diameter in the range of 18-42mm; and 3) non-aneurysmal aortic proximal and distal neck lengths >=20mm.
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 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S034 S035 S036 S037 
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