Approval for a labeling change to modify the sizing convention from outer diameter to inner diameter of the graft.
| Device | ARTEGRAFT COLLAGEN VASCULAR GRAFT |
| Classification Name | Tissue Graft Of 6mm And Greater |
| Generic Name | Tissue Graft Of 6mm And Greater |
| Applicant | ARTEGRAFT, INC. |
| Date Received | 2014-07-07 |
| Decision Date | 2014-07-14 |
| PMA | N16837 |
| Supplement | S015 |
| Product Code | LXA |
| 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 | ARTEGRAFT, INC. 206-208b North Center Drive north Brunswick, NJ 08902 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| N16837 | | Original Filing |
| S029 |
2022-12-30 |
30-day Notice |
| S028 |
2022-09-16 |
30-day Notice |
| S027 | | |
| S026 |
2020-04-07 |
30-day Notice |
| S025 |
2018-06-15 |
30-day Notice |
| S024 |
2017-12-29 |
30-day Notice |
| S023 |
2017-12-19 |
30-day Notice |
| S022 |
2017-08-16 |
30-day Notice |
| S021 |
2015-09-11 |
Real-time Process |
| S020 |
2015-04-01 |
Special (immediate Track) |
| S019 |
2015-03-06 |
Real-time Process |
| S018 |
2014-09-04 |
30-day Notice |
| S017 |
2014-07-30 |
30-day Notice |
| S016 | | |
| S015 |
2014-07-07 |
Special (immediate Track) |
| S014 |
2014-06-11 |
Real-time Process |
| S013 | | |
| S012 |
2014-02-27 |
30-day Notice |
| S011 |
2013-04-26 |
Normal 180 Day Track No User Fee |
| S010 |
2012-09-24 |
135 Review Track For 30-day Notice |
| S009 |
2011-12-28 |
135 Review Track For 30-day Notice |
| S008 |
2011-09-20 |
135 Review Track For 30-day Notice |
| S007 |
2009-06-22 |
30-day Notice |
| S006 |
2008-08-11 |
135 Review Track For 30-day Notice |
| S005 |
2006-11-03 |
Real-time Process |
| S004 |
2006-02-01 |
30-day Notice |
| S003 |
1999-07-29 |
Normal 180 Day Track |
| S002 | | |
| S001 |
1979-06-29 |
|
NIH GUDID Devices