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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.
 
DeviceEluvia Drug-Eluting Vascular Stent System
Generic NameStent, superficial femoral artery, drug-eluting
ApplicantBoston Scientific Corp.
One Scimed Place
Maple Grove, MN 55311
PMA NumberP180011
Supplement NumberS052
Date Received12/15/2022
Decision Date04/10/2023
Product Code NIU 
Advisory Committee Cardiovascular
Clinical TrialsNCT02574481
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval to update the labeling to include the long-term results of the IMPERIAL continued follow-up and REGAL post-approval studies
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