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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 NumberS005
Date Received03/01/2019
Decision Date03/18/2019
Product Code NIU 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Addition of an alternate nitinol tubing supplier.
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