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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM
Classification Namestent, iliac
ApplicantCORDIS CORP.
PMA NumberP020036
Supplement NumberS012
Date Received12/03/2008
Decision Date12/11/2008
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
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 smart stent systems.
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