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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 TAA STENT GRAFT DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Applicant MEDTRONIC INC.
PMA NumberP070007
Supplement NumberS018
Date Received05/05/2010
Decision Date06/18/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization site located at isotron ireland ltd, offaly, ireland, as an alternative e-beam sterilization site.
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