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 protocols for the post-approval studies (pas) referenced above. The pas protocols have been submitted to comply with the conditions of approval outlined in our approval order for p170042/s002
| 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 | 2019-04-01 |
| Decision Date | 2019-10-31 |
| PMA | P170042 |
| Supplement | S003 |
| Product Code | PFV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | C.R. Bard, Inc 1625 W. 3rd Street tempe, AZ 85528 |
| 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) |