This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM} |
| Classification Name | Tissue Graft Of 6mm And Greater |
| Generic Name | Tissue Graft Of 6mm And Greater |
| Applicant | ARTEGRAFT, INC. |
| Date Received | 1979-07-01 |
| Decision Date | 1979-08-01 |
| PMA | N16837 |
| Supplement | S |
| Product Code | LXA |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ARTEGRAFT, INC. 206-208b North Center Drive north Brunswick, NJ 08902 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00316837000367 | N16837 | 000 |
| 00316837000190 | N16837 | 015 |
| 00316837000206 | N16837 | 015 |
| 00316837000213 | N16837 | 015 |
| 00316837000220 | N16837 | 015 |
| 00316837000237 | N16837 | 015 |
| 00316837000244 | N16837 | 015 |
| 00316837000251 | N16837 | 015 |
| 00316837000268 | N16837 | 015 |
| 00316837000275 | N16837 | 015 |
| 00316837000282 | N16837 | 015 |
| 00316837000299 | N16837 | 015 |
| 00316837000305 | N16837 | 015 |
| 00316837000312 | N16837 | 015 |
| 00316837000329 | N16837 | 015 |
| 00316837000336 | N16837 | 015 |
| 00316837000343 | N16837 | 015 |
| 00316837000350 | N16837 | 015 |