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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRX ACCULINK CARTOID STENT SYSTEM
Generic NameStent, carotid
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP040012
Supplement NumberS044
Date Received03/20/2012
Decision Date08/24/2012
Product Code NIM 
Advisory Committee Cardiovascular
Clinical TrialsNCT00004732
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE LABELING WITH LONG TERM CREST STUDY RESULTS.
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