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.
The addition of a new laser for welding radiopaque markers to the stent
| Device | Bard Fluency Plus Endovascular Stent Graft |
| Generic Name | System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2021-02-25 |
| Decision Date | 2021-03-23 |
| PMA | P130029 |
| Supplement | S009 |
| 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 | BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130029 | Original Filing | |
| S011 | 2021-08-26 | Real-time Process |
| S010 | 2021-07-09 | 30-day Notice |
| S009 | 2021-02-25 | 30-day Notice |
| S008 | 2020-05-01 | 30-day Notice |
| S007 | 2017-04-10 | Normal 180 Day Track No User Fee |
| S006 | 2016-11-30 | 135 Review Track For 30-day Notice |
| S005 | ||
| S004 | 2016-02-12 | Normal 180 Day Track No User Fee |
| S003 | 2015-06-15 | Special (immediate Track) |
| S002 | 2015-05-01 | Panel Track |
| S001 | 2015-04-08 | 135 Review Track For 30-day Notice |