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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.
 
DeviceS.M.A.R.T CONTROL NITINOL STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
CORDIS CORP.
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP020036
Supplement NumberS010
Date Received07/18/2008
Decision Date08/07/2008
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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