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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 Pl.
Maple Grove, MN 55311
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
Predetermined Change Control Plan AuthorizedNo
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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