|
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 |
Supplement Number | S002 |
Date Received | 09/04/2018 |
Decision Date | 03/01/2019 |
Product Code |
PFV |
Docket Number | 19M-0995 |
Notice Date | 03/07/2019 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02649946
|
Supplement Type | Panel 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 Study | Show Report Schedule and Study Progress |