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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 NameVALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP100040
Supplement NumberS013
Date Received11/04/2013
Decision Date01/07/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a product line extension consisting of the addition of 11 valiant freeflo tapered stent grafts. The device, as modified, will be marketed under the trade name valiant thoracic stent graft system with captivia delivery system and is indicated for the endovascular repair of isolated lesions (excluding dissections) of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/penetrating ulcers) or 18 mm to 44 mm (blunt traumatic aortic injuries); and nonaneurysmal aortic proximal and distal neck lengths ¿ 20 mm.
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