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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 NumberS009
Date Received05/04/2021
Decision Date06/03/2021
Product Code PFV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
New supplier and manufacturing processes for delivery system handle components.
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