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 | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 1980-01-18 |
| Decision Date | 1980-10-24 |
| Notice Date | 1983-02-15 |
| PMA | P800002 |
| Supplement | S |
| Product Code | LMF |
| Docket Number | 83M-0026 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | C.R. Bard, Inc. 160 New Boston Street woburn, MA 01801 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800002 | Original Filing | |
| S028 | 2021-01-19 | 30-day Notice |
| S027 | ||
| S026 | 2020-02-28 | 30-day Notice |
| S025 | 2019-05-20 | 30-day Notice |
| S024 | 2018-12-03 | 30-day Notice |
| S023 | 2018-06-28 | 30-day Notice |
| S022 | 2017-03-27 | 135 Review Track For 30-day Notice |
| S021 | 2014-05-30 | 30-day Notice |
| S020 | 2013-12-11 | 30-day Notice |
| S019 | 2013-06-24 | 30-day Notice |
| S018 | 2011-12-22 | Special (immediate Track) |
| S017 | 2011-09-02 | 30-day Notice |
| S016 | 2009-03-20 | 30-day Notice |
| S015 | 2005-09-08 | 30-day Notice |
| S014 | 2004-10-04 | 30-day Notice |
| S013 | 2003-06-11 | 30-day Notice |
| S012 | 2001-05-23 | 30-day Notice |
| S011 | 1998-07-21 | 30-day Notice |
| S010 | 1993-12-02 | Normal 180 Day Track |
| S009 | 1992-01-21 | Normal 180 Day Track |
| S008 | 1991-10-16 | Normal 180 Day Track |
| S007 | 1988-03-08 | Normal 180 Day Track |
| S006 | ||
| S005 | 1983-10-11 | |
| S004 | 1983-08-30 | |
| S003 | 1982-01-07 | |
| S002 | 1981-01-27 | |
| S001 | 1981-04-09 |
| Device ID | PMA | Supp |
|---|---|---|
| 10801741010474 | P800002 | 000 |
| 10801741010467 | P800002 | 000 |
| 10801741010450 | P800002 | 000 |
| 10801741010474 | P800002 | 001 |
| 10801741010467 | P800002 | 001 |
| 10801741010450 | P800002 | 001 |
| 10801741010498 | P800002 | 008 |
| 10801741010481 | P800002 | 008 |