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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 NameSAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Classification Namestent, iliac
ApplicantCORDIS CORP.
PMA NumberP020036
Supplement NumberS016
Date Received04/19/2010
Decision Date02/14/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in colorant used in the catheters of the precise and smart nitinol stent systems.
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