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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 SYSTEMS
Classification Namestent, iliac
ApplicantCORDIS CORP.
PMA NumberP020036
Supplement NumberS017
Date Received02/16/2010
Decision Date03/17/2010
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in packaging configuration.
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