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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 CAPTIVIA AND WITH THE XCELERANT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR INC
PMA NumberP070007
Supplement NumberS031
Date Received06/14/2011
Decision Date07/13/2011
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
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