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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, carotid
Generic Namestent, carotid
Boston Scientific Corp.
2011 stierlin ct.
mountain view, CA 94043-4655
PMA NumberP050019
Date Received05/24/2005
Decision Date10/23/2008
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 08M-0596
Notice Date 12/01/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the carotid wallstent monorail endoprosthesis. The device, used inconjunction with the boston scientific embolic protection system, is indicated for the treatmentof patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral orbilateral carotid artery disease and meet the criteria outlined below:1) patients with neurological symptoms and > 50% stenosis of the common, internal carotidartery and/or the bifurcation by ultrasound or angiogram, or patients without neurologicalsymptoms and > 80% stenosis of the common, internal carotid artery and/or thebifurcation by ultrasound or angiogram, and;2) patients with a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at thetarget lesion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S021 S022 S023 S024 S025