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.
To implement an alternative external process challenge device (epcd) used in the sterilization process
| Device | Covera Vascular Covered Stent |
| Generic Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Applicant | C.R. Bard, Inc |
| Date Received | 2021-07-09 |
| Decision Date | 2021-08-05 |
| PMA | P170042 |
| Supplement | S010 |
| Product Code | PFV |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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) |