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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
Generic NameSTENT, CAROTID
ApplicantBoston Scientific Corp.
Three Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP050019
Date Received05/24/2005
Decision Date10/23/2008
Product Code NIM 
Docket Number 08M-0596
Notice Date 12/01/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S007 S008 S022 S023 S012 S014 S011 S003 S004 S001 S006 
S025 S017 S018 S019 S013 S021 S010 S009 S015 S016 S005 S002 
S024 S028 S026 S030 S031 S034 S037 S038 S029 S033 S035 S036 
S032 S039 S040 S041 
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