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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 NameRX ACCULINK CAROTID STENT SYSTEM
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
ApplicantABBOTT VASCULAR INC.
PMA NumberP040012
Supplement NumberS042
Date Received09/19/2011
Decision Date03/29/2012
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of the emboshield family of embolic protection systems (eps) to the standard risk indication and an update to the magnetic resonance compatibility section of the labeling.
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