Approval for modifications to the device instructions for use to include language to improve the safety in use of the device, predominantly with respect to the potential for device migrations.
| Device | BARD 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 | 2010-03-19 |
| Decision Date | 2010-04-16 |
| PMA | P060002 |
| Supplement | S011 |
| Product Code | PFV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BARD PERIPHERAL VASCULAR 1625 W. Third St tempe, AZ 85281 |
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