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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP100040
Date Received10/08/2010
Decision Date04/01/2011
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 11M-0257
Notice Date 04/20/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00413231
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the faliant thoracic stent graft with the captiva delivery system. The device is indicated for the endovascular repair of fusiform and aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac/femoral access vessle morphology that is compatible with vascular access techniques, devices, and/or accessories; 2) non-aneurysmal aortic diameter in the range of 18-42 mm; and 3) non-aneurysmal aortic proximal and distal neck lengths >=20 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S019 
S020 S021 S022 S023 S024 S025 S026 S027