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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
Classification Namestent, superficial femoral artery, drug-eluting
Generic Namestent, superficial femoral artery, drug-eluting
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311
PMA NumberP180011
Date Received04/13/2018
Decision Date09/18/2018
Product Code
NIU[ Registered Establishments with NIU ]
Docket Number 18M-3548
Notice Date 09/20/2018
Advisory Committee Cardiovascular
Clinical Trials NCT02574481
Expedited Review Granted? No
Combination Product Yes
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 
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