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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 WITH THE XCELERANT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Applicant MEDTRONIC INC.
PMA NumberP070007
Supplement NumberS012
Date Received09/17/2009
Decision Date10/23/2009
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medtronic cardiac surgery, medtronic perfusion systems, minneapolis, minnesota. The proposed site will be performing rework of packaging and labeling.
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