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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.
 
DeviceCORDIS SMART CONTROL NITINOL STENT SYSTEMS
Generic NameSTENT, ILIAC
ApplicantCordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014
PMA NumberP020036
Supplement NumberS032
Date Received03/18/2015
Decision Date04/16/2015
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  
REMOVAL OF A REDUNDANT MANUFACTURING IN-PROCESS WATERBORNE TESTING STEP USED IN THE STENT CLEANING PROCESS.
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