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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 OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantCordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014
PMA NumberP030047
Supplement NumberS001
Date Received09/27/2006
Decision Date11/16/2006
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PRECISE? RX NITINOL STENT SYSTEM.
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