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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/PRECISE PRO RX NITINOL STENT SYSTEMS
Generic Namestent, carotid
ApplicantCordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP030047
Supplement NumberS020
Date Received02/16/2010
Decision Date03/17/2010
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN PACKAGING CONFIGURATION.
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