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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 NameSMART AND SMART CONTROL VASCULAR STENT SYSTEM
Classification Namestent, superficial femoral artery
ApplicantCORDIS CORP.
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: manufacturing
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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