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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.
 
DevicePromus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP110010
Supplement NumberS164
Date Received03/08/2019
Decision Date01/03/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT01589978
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for revisions to the labeling that incorporate the results of the PROMUS Element Plus Post-Approval Study.
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