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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 ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP070027
Supplement NumberS029
Date Received02/14/2011
Decision Date08/18/2011
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for automation of your inventory management system.
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