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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.
 
DevicePRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS
Generic Namestent, carotid
ApplicantCordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP030047
Supplement NumberS024
Date Received02/23/2012
Decision Date03/22/2012
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  
PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS.
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