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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
ApplicantMEDTRONIC VASCULAR
PMA NumberP070007
Supplement NumberS003
Date Received08/18/2008
Decision Date05/21/2009
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the current manufacturing process used by the supplier of stent components for the device.
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