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 an update to the inspection procedure for the bond peel strength test for the flair and fluency plus endovascular stent graft systems.
| 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 | 2016-11-30 |
| Decision Date | 2017-11-28 |
| PMA | P130029 |
| Supplement | S006 |
| Product Code | PFV |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 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 |