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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
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantC.R. Bard, Inc.
1625 W. 3rd St.
Tempe, AZ 85528
PMA NumberP170042
Supplement NumberS011
Date Received08/20/2021
Decision Date03/24/2022
Product Code PFV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the labeling to include the 36-month data on patients enrolled in the AVeNEW IDE extended follow-up study.
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