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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.
 
DeviceCOMPLETE SE VASCULAR STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP090006
Supplement NumberS002
Date Received07/19/2010
Decision Date02/15/2011
Withdrawal Date 05/23/2019
Product Code NIO 
Advisory Committee Cardiovascular
Clinical TrialsNCT00730730
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE 120MM LENGTH COMPLETE SE VASCULAR STENT.
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