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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 NameACCULINK CAROTID STENT SYSTEM
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
ApplicantABBOTT VASCULAR INC.
PMA NumberP040012
Supplement NumberS035
Date Received10/05/2010
Decision Date11/01/2010
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Discontinuation of the quarterly pyrogen testing of the above named pre- and post-e-beam sterilized products.
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