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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.
 
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
Supplement NumberS002
Date Received09/04/2018
Decision Date03/01/2019
Product Code
PFV[ Registered Establishments with PFV ]
Docket Number 19M-0995
Notice Date 03/07/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02649946
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the COVERA Vascular Covered Stent. The device is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous fistula and at the venous anastomosis of an ePTFE or other synthetic AV graft.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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