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Device | Covera™ Vascular Covered Stent |
Generic Name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
Applicant | C.R. Bard, Inc 1625 W. 3rd Street Tempe, AZ 85528 |
PMA Number | P170042 |
Date Received | 12/12/2017 |
Decision Date | 07/30/2018 |
Product Code |
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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012
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