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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 CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC VASCULAR
PMA NumberP070027
Supplement NumberS032
Date Received09/20/2011
Decision Date05/10/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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