This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| 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 | 2017-12-12 |
| Decision Date | 2018-07-30 |
| Notice Date | 2018-08-01 |
| PMA | P170042 |
| Supplement | S |
| Product Code | PFV |
| Docket Number | 18M-2983 |
| Advisory Committee | Cardiovascular |
| 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) |