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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 Pl.
Maple Grove, MN 55311
PMA NumberP180011
Supplement NumberS046
Date Received10/01/2021
Decision Date12/23/2021
Product Code NIU 
Advisory Committee Cardiovascular
Clinical TrialsNCT02574481
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the introduction of a 150mm length Eluvia device, reintroduction of 180mm and 200mm Innova devices, and delivery system shaft modifications.
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