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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 NameRX ACCULINK CARTOID STENT SYSTEM
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
ApplicantABBOTT VASCULAR INC.
PMA NumberP040012
Supplement NumberS043
Date Received11/21/2011
Decision Date12/13/2011
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in irradiation equipment.
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