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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 NumberS035
Date Received11/08/2022
Decision Date02/01/2023
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stent delivery system.
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