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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 ENDOPROSTHESIS
Generic NameStent, carotid
ApplicantBoston Scientific Corp
Three Scimed Pl.
Maple Grove, MN 55311
PMA NumberP050019
Supplement NumberS021
Date Received02/23/2015
Decision Date05/15/2015
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
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 CHANGES RELATED TO THE MR COMPATIBILITY OF THE DEVICE.
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