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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.
 
DeviceENROUTE TRANSCAROTID STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP140026
Date Received11/17/2014
Decision Date05/18/2015
Product Code NIM 
Docket Number 15M-1956
Notice Date 06/02/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01685567
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ENROUTE TRANSCAROTID STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) FOR THE TREATMENT OF PATIENTS AT HIGH RISKFOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW.1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >= 50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM; 2) PATIENTS MUST HAVE A VESSEL DIAMETER OF 4-9MM AT THE TARGET LESION; AND 3) CAROTID BIFURCATION IS LOCATED AT MINIMUM 5 CM ABOVE THE CLAVICLE TO ALLOW FOR PLACEMENT OF THE ENROUTE TRANSCAROTID NPS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S009 S015 S005 S006 S002 S001  S024 S003 S004 S030 S008 
S010 S013 S011 S014 S012 S020 S021 S023 S016 S017 S025 S026 
S018 S019 S028 S029 S031 S027 
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