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 for the fluency plus endovascular stent graft. This device is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.
| Device | FLUENCY PLUS ENDOVASCULAR STENT GRAFT |
| 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 | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2015-05-01 |
| Decision Date | 2016-04-26 |
| Notice Date | 2016-05-12 |
| PMA | P130029 |
| Supplement | S002 |
| Product Code | PFV |
| Docket Number | 16M-1223 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |