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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 DEVICES
PMA NumberP040038
Supplement NumberS015
Date Received12/15/2008
Decision Date07/23/2009
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling to include the post-approval study findings.
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