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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 NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM
Generic NameStent, carotid
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP030047
Supplement NumberS016
Date Received12/03/2008
Decision Date12/24/2008
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO INCORPORATE AN ADDITIONAL PRECAUTION INTO THE INSTRUCTIONS FOR USE TO ADDRESS THE POTENTIAL FOR STENT FRACTURES THAT MAY OCCUR WITH SELF-EXPANDING STENTS SUCH AS THE CORDIS PRECISE STENT SYSTEMS.
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