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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.
 
DeviceSMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantCordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014
PMA NumberP020036
Supplement NumberS025
Date Received04/24/2012
Decision Date05/22/2012
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  
IMPLEMENTATION OF A VISION SYSTEM FOR THE INSPECTION OF POUCH SEALS.
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