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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.
 
DeviceSMART AND SMART CONTROL VASCULAR STENT SYSTEM
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
CORDIS CORP.
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP120002
Supplement NumberS001
Date Received03/24/2014
Decision Date04/16/2014
Product Code
NIP[ Registered Establishments with NIP ]
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 
Add an additional semi-automated inspection step to the current pouch sealing inspection.
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