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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 NameTHE TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Applicant MEDTRONIC INC.
PMA NumberP070027
Supplement NumberS017
Date Received05/03/2010
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 manufacturing site located at medtronic ireland, galway, ireland, for final assembly processes and for isotron ireland, ltd. , tullamore, ireland, for sterilization services.
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