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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 NameMEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP100021
Date Received06/04/2010
Decision Date12/16/2010
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 11M-0040
Notice Date 01/25/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00870051
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the endurant stent graft system. The device is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients with the following characteristics: 1) adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) proximal neck length of >= 10mm; 3) infrarenal neck angulation <= 60 degrees; 4) distal fixation length of >= 15 mm; 5) aortic neck diameters with a range of 19 to 32 mm; 6) iliac diameters with a range of 8 to 25 mm; and 7) morphology suitable for aneurysm repair.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 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 S033 
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