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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 NameS.M.A.R.T CONTROL NITINOL STENT SYSTEM
Classification Namestent, iliac
Generic Nameiliac stent
ApplicantCORDIS CORP.
PMA NumberP020036
Supplement NumberS010
Date Received07/18/2008
Decision Date08/07/2008
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to incorporate a functional torque specification for the slider assembly of the smart control nitinol stent delivery system.
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