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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.
 
DeviceS.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP020036
Supplement NumberS033
Date Received03/19/2015
Decision Date11/25/2015
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF PERFLUORO-OCTANOIC ACID (PFOA) FROM THE POLYTETRAFLUORO-ETHYLENE (PTFE) TUBING.
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