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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 NameTALENT THORACIC STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Applicant MEDTRONIC INC.
PMA NumberP070007
Supplement NumberS021
Date Received08/30/2010
Decision Date10/26/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Clinical Trials NCT00604799
NCT01181947
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two new longer length proximal main stent grafts, the new captivia delivery system, and a new sterilization site.
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