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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.
 
DeviceCovera™ Vascular Covered Stent
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantC.R. Bard, Inc.
1625 W. 3rd St.
Tempe, AZ 85528
PMA NumberP170042
Date Received12/12/2017
Decision Date07/30/2018
Product Code PFV 
Docket Number 18M-2983
Notice Date 08/01/2018
Advisory Committee Cardiovascular
Clinical TrialsNCT02790606
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the Covera™ Vascular Covered Stent. This device is indicated for use in the treatment of stenoses at the venous anastomosis of ePTFE and other synthetic arterio-venous (AV) access grafts.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 
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