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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.
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
PMA NumberP040012
Supplement NumberS050
Date Received10/31/2012
Decision Date12/19/2012
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the rx acculink carotid stent systems bonding of the inner member, guidewire lumen and notched hypotube.