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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 THORACIC STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP070007
Supplement NumberS021
Date Received08/30/2010
Decision Date10/26/2010
Withdrawal Date 05/10/2016
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT00604799
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR TWO NEW LONGER LENGTH PROXIMAL MAIN STENT GRAFTS, THE NEW CAPTIVIA DELIVERY SYSTEM, AND A NEW STERILIZATION SITE.
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