Covera Vascular Covered Stent

FDA Premarket Approval P170042 S006

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.

Pre-market Approval Supplement Details

Modifications to the delivery system joint bonding process

DeviceCovera Vascular Covered Stent
Generic NameSystem, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
ApplicantC.R. Bard, Inc
Date Received2020-08-03
Decision Date2020-08-20
PMAP170042
SupplementS006
Product CodePFV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address C.R. Bard, Inc 1625 W. 3rd Street tempe, AZ 85528

Supplemental Filings

Supplement NumberDateSupplement Type
P170042Original Filing
S006 2020-08-03 30-day Notice
S005
S004
S003 2019-04-01 Normal 180 Day Track No User Fee
S002 2018-09-04 Panel Track
S001 2018-08-20 Special (immediate Track)

NIH GUDID Devices

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