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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENROUTE Transcarotid Stent System
Generic NameSTENT, CAROTID
ApplicantBoston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP140026
Supplement NumberS016
Date Received02/23/2021
Decision Date04/28/2022
Product Code NIM 
Docket Number 22M-0746
Notice Date 05/06/2022
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the expansion of the Indications for Use to include treatment of patients at standard risk for adverse events from carotid endartectomy.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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