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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.
 
DeviceSAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
CORDIS CORP.
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP020036
Supplement NumberS016
Date Received03/30/2010
Decision Date02/14/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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