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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 NumberS007
Date Received08/08/2011
Decision Date09/07/2011
Withdrawal Date 05/23/2019
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REDUCTION IN PYROGEN TESTING SAMPLE SIZE.
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