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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 PRECISE RX NITINOL STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantCordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014
PMA NumberP030047
Supplement NumberS010
Date Received12/17/2007
Decision Date01/16/2008
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING MATERIALS FOR THE PROCESSING AID, WHICH IS USED TO TACK THE SUPPORT MEMBER SLEEVE IN PLACE WHILE THE SLEEVE IS HEAT-SHRUNK OVER THE ENTIRE ASSEMBLY.
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