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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 NumberS040
Date Received07/31/2023
Decision Date03/08/2024
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of an alternate sterilization site, Synergy Health Ede. B.V. (STERIS) in the Netherlands
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