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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 Namestent, carotid
3200 lakeside drive
santa clara, CA 95054
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 change - pas
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.