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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 NumberS006
Date Received10/12/2006
Decision Date11/09/2006
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the acceptance criterion for a production inspection for the s. M. A. R. T. Control nitinol stent system.
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