This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | C.R. Bard, Inc. |
| Date Received | 1992-01-21 |
| Decision Date | 1993-04-09 |
| PMA | P800002 |
| Supplement | S009 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |