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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 NameXACT CAROTID STENT SYSTEM
Classification Namestent, carotid
Generic Namecarotid stent system
ApplicantABBOTT VASCULAR INC.
PMA NumberP040038
Supplement NumberS024
Date Received02/27/2012
Decision Date07/24/2012
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Clinical Trials NCT00287508
NCT00402740
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the protect post-approval study (pas) results to the instructions for use (ifu).
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