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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 NumberS008
Date Received12/31/2006
Decision Date01/19/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the processes and components used to manufacture the stent delivery system handle.
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