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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
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
Date Received04/13/2018
Decision Date09/18/2018
Product Code NIU 
Docket Number 18M-3548
Notice Date 09/20/2018
Advisory Committee Cardiovascular
Clinical TrialsNCT02574481
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the ELUVIA Drug-Eluting Vascular Stent System. The device is indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0 - 6.0 mm and total lesion lengths up to 190 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S043 S051 S038 S039 S040 S048 S056 S052 S044 S045 S046 S047 
S041 S050 S049 S007 S008 S036 S037 S022 S023 S024 S025 S026 
S027 S030 S031 S014 S015 S016 S001 S002 S003 S017 S018 S019 
S020 S021 S010 S011 S012 S013 S034 S035 S042 S053 S054 S028 
S029 S032 S033 S009 S004 S005