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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.
 
DeviceNITINOL 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 NumberS023
Date Received02/23/2012
Decision Date03/22/2012
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Package handling change to the heat sealing process.
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