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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.
Classification Namestent, carotid
Generic Namecarotid stent system and embolic protection system
PMA NumberP040012
Supplement NumberS031
Date Received11/02/2009
Decision Date04/30/2010
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the indication statement and instructions for use to incorporate use with the emboshield embolic protection system. The device, as modified, will be marketed under the trade name rx acculink carotid stem system and is indicated for use in conjunction with abbott vascular's accunet or emboshield family of embolic protection systems, for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria as previously approved.