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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 NumberS013
Date Received06/09/2008
Decision Date11/10/2008
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to move the xact manufacturing processes within the existing manufacturing facility and to move two pieces of duplicate manufacturing equipment from one building to another.
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