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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 NumberS027
Date Received09/27/2007
Decision Date02/21/2008
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications of the device labeling to include an additional warning and a summary of the capture post-approval study. The device, as modified, will be marketed under the trade name rx accuylink carotid stent system and, used in conjunction with abbott vascular x accunet embolic protection systems, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require revascularization and meet the following criteria: 1) patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients with out neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and 2) patients must have a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion.