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 | MICROFIBRILLAR COLLAGEN HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. |
| Date Received | 1983-08-26 |
| Decision Date | 1983-11-17 |
| PMA | N17600 |
| Supplement | S008 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAVOL, INC., SUB. C.R. BARD, INC. 100 Crossings Boulevard warwick, RI 02886 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17600 | Original Filing | |
| S035 | 2021-01-19 | 30-day Notice |
| S034 | ||
| S033 | 2020-02-28 | 30-day Notice |
| S032 | 2019-05-20 | 30-day Notice |
| S031 | 2018-12-03 | 30-day Notice |
| S030 | 2018-06-28 | 30-day Notice |
| S029 | 2014-05-30 | 30-day Notice |
| S028 | 2013-06-24 | 30-day Notice |
| S027 | 2013-05-28 | 30-day Notice |
| S026 | 2011-12-22 | Special (immediate Track) |
| S025 | 2011-09-02 | 30-day Notice |
| S024 | 2009-03-20 | 30-day Notice |
| S023 | 2005-09-08 | 30-day Notice |
| S022 | ||
| S021 | 2004-10-04 | 30-day Notice |
| S020 | 2003-06-11 | 30-day Notice |
| S019 | 2001-10-18 | Real-time Process |
| S018 | 2001-05-23 | 30-day Notice |
| S017 | 2000-12-14 | Normal 180 Day Track |
| S016 | 1998-12-21 | Real-time Process |
| S015 | 1998-07-21 | 30-day Notice |
| S014 | 1995-03-16 | Normal 180 Day Track |
| S013 | 1995-01-23 | Normal 180 Day Track |
| S012 | 1994-06-07 | Normal 180 Day Track |
| S011 | 1993-08-23 | Normal 180 Day Track |
| S010 | 1991-10-07 | Normal 180 Day Track |
| S009 | 1986-09-16 | Special (immediate Track) |
| S008 | 1983-08-26 | |
| S007 | 1982-02-02 | |
| S006 | ||
| S005 | 1981-08-20 | |
| S004 | 1980-07-21 | |
| S003 | 1980-07-08 | |
| S002 | 1980-06-16 | |
| S001 | 1980-01-28 |
| Device ID | PMA | Supp |
|---|---|---|
| 10801741000383 | N17600 | 000 |
| 10801741010436 | N17600 | 000 |
| 10801741010511 | N17600 | 000 |
| 10801741000383 | N17600 | 001 |
| 10801741010436 | N17600 | 001 |
| 10801741010511 | N17600 | 001 |
| 10801741010504 | N17600 | 011 |
| 10801741010528 | N17600 | 016 |
| 10801741010535 | N17600 | 016 |
| 10801741010542 | N17600 | 016 |
| 10801741010559 | N17600 | 016 |
| 10801741223102 | N17600 | 038 |