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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
Marborough, MA 01752
PMA NumberP140026
Supplement NumberS005
Date Received01/31/2017
Decision Date07/18/2017
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day 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 labeling updates to incorporate the ROADSTER Study Continued Access data.
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