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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTALENT ABDOMINAL STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP070027
Supplement NumberS005
Date Received12/19/2008
Decision Date01/16/2009
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR STERILIZATION OF THE DEVICE.
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