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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
Classification Namesystem, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Generic Namesystem, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Applicant
C.R. Bard, Inc
1625 w. 3rd street
tempe, AZ 85528
PMA NumberP170042
Date Received12/12/2017
Decision Date07/30/2018
Product Code
PFV[ Registered Establishments with PFV ]
Docket Number 18M-2983
Notice Date 08/01/2018
Advisory Committee Cardiovascular
Clinical Trials NCT02790606
Expedited Review Granted? No
Combination Product No
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 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 
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