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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.
 
DeviceCarotid Wallstent Monorail Endoprosthesis
Generic NameSTENT, CAROTID
ApplicantBoston Scientific Corp.
Three Scimed Place
Maple Grove, MN 55311-1566
PMA NumberP050019
Supplement NumberS029
Date Received01/26/2018
Decision Date02/22/2018
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update the visual acceptance criteria of a thermal bond for a delivery system component.
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