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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 CARTOID STENT SYSTEM
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
ApplicantABBOTT VASCULAR INC.
PMA NumberP040012
Supplement NumberS044
Date Received03/20/2012
Decision Date08/24/2012
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Clinical Trials NCT00004732
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the labeling with long term crest study results.
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