Approval for the flair endovascular stent graft. The device is indicated for use in the treatment of stenoses at the venous anastomosis of eptfe or other synthetic arteriovenous (av) access grafts.
| Device | FLAIR 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 |
| Date Received | 2006-01-17 |
| Decision Date | 2007-07-23 |
| Notice Date | 2007-08-01 |
| PMA | P060002 |
| Supplement | S |
| Product Code | PFV |
| Docket Number | 07M-0298 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BARD PERIPHERAL VASCULAR 1625 W. Third St tempe, AZ 85281 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060002 | | Original Filing |
| S040 |
2018-03-16 |
135 Review Track For 30-day Notice |
| S039 |
2017-06-19 |
30-day Notice |
| S038 |
2016-11-30 |
135 Review Track For 30-day Notice |
| S037 | | |
| S036 |
2015-04-08 |
135 Review Track For 30-day Notice |
| S035 |
2014-03-24 |
30-day Notice |
| S034 |
2014-02-14 |
Normal 180 Day Track No User Fee |
| S033 |
2013-08-21 |
30-day Notice |
| S032 |
2013-05-09 |
30-day Notice |
| S031 |
2013-04-05 |
30-day Notice |
| S030 |
2013-03-29 |
30-day Notice |
| S029 |
2013-02-19 |
30-day Notice |
| S028 |
2012-09-27 |
Special (immediate Track) |
| S027 |
2012-07-19 |
Normal 180 Day Track |
| S026 |
2012-05-21 |
30-day Notice |
| S025 |
2012-04-02 |
30-day Notice |
| S024 |
2012-02-01 |
135 Review Track For 30-day Notice |
| S023 | | |
| S022 |
2011-10-28 |
30-day Notice |
| S021 |
2011-10-21 |
30-day Notice |
| S020 |
2011-08-26 |
30-day Notice |
| S019 | | |
| S018 | | |
| S017 |
2011-01-20 |
30-day Notice |
| S016 |
2010-08-10 |
30-day Notice |
| S015 |
2010-08-10 |
30-day Notice |
| S014 |
2010-07-28 |
30-day Notice |
| S013 |
2010-07-20 |
30-day Notice |
| S012 | | |
| S011 |
2010-03-19 |
Special (immediate Track) |
| S010 |
2010-03-19 |
135 Review Track For 30-day Notice |
| S009 |
2009-11-19 |
30-day Notice |
| S008 |
2009-11-18 |
30-day Notice |
| S007 |
2009-11-05 |
30-day Notice |
| S006 |
2009-09-30 |
Normal 180 Day Track No User Fee |
| S005 |
2009-07-22 |
Normal 180 Day Track No User Fee |
| S004 |
2009-02-02 |
30-day Notice |
| S003 |
2008-08-29 |
Special (immediate Track) |
| S002 |
2008-03-20 |
Normal 180 Day Track |
| S001 |
2007-08-22 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices