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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 ILIAC VASCULAR STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP090006
Supplement NumberS012
Date Received12/16/2013
Decision Date01/14/2014
Withdrawal Date05/23/2019
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO YOUR BIOBURDEN TEST METHOD.
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