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.
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.
| Device | Covera™ Vascular Covered Stent |
| Classification Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Generic Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Applicant | C.R. Bard, Inc |
| Date Received | 2018-09-04 |
| Decision Date | 2019-03-01 |
| Notice Date | 2019-03-07 |
| PMA | P170042 |
| Supplement | S002 |
| Product Code | PFV |
| Docket Number | 19M-0995 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | C.R. Bard, Inc 1625 W. 3rd Street tempe, AZ 85528 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170042 | Original Filing | |
| S012 | 2023-01-06 | 30-day Notice |
| S011 | 2021-08-20 | Normal 180 Day Track No User Fee |
| S010 | 2021-07-09 | 30-day Notice |
| S009 | 2021-05-04 | 30-day Notice |
| S008 | 2020-09-01 | 30-day Notice |
| S007 | 2020-08-31 | 30-day Notice |
| 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) |