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 | SURGICEL BRAND ABSORBABLE HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 1960-10-14 |
| Decision Date | 1960-10-14 |
| PMA | N12159 |
| Supplement | S |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ETHICON, INC. route 22 West somerville, NJ 08876 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N12159 | Original Filing | |
| S096 | 2022-11-21 | 30-day Notice |
| S095 | ||
| S094 | 2022-06-08 | 30-day Notice |
| S093 | ||
| S092 | 2022-04-26 | 30-day Notice |
| S091 | 2021-12-20 | 30-day Notice |
| S090 | 2021-12-20 | 30-day Notice |
| S089 | ||
| S088 | ||
| S087 | 2021-09-22 | 30-day Notice |
| S086 | ||
| S085 | ||
| S084 | 2021-08-30 | 30-day Notice |
| S083 | 2021-08-12 | 30-day Notice |
| S082 | 2021-08-02 | 30-day Notice |
| S081 | 2021-07-22 | 30-day Notice |
| S080 | 2021-07-01 | 30-day Notice |
| S079 | 2021-03-03 | 30-day Notice |
| S078 | 2021-03-03 | 30-day Notice |
| S077 | 2020-11-25 | 30-day Notice |
| S076 | 2020-10-15 | 30-day Notice |
| S075 | 2020-10-06 | 30-day Notice |
| S074 | 2020-07-20 | 30-day Notice |
| S073 | ||
| S072 | 2020-06-15 | 30-day Notice |
| S071 | ||
| S070 | 2020-03-20 | 30-day Notice |
| S069 | ||
| S068 | 2020-02-04 | 30-day Notice |
| S067 | 2019-11-04 | 30-day Notice |
| S066 | 2019-10-23 | 30-day Notice |
| S065 | 2019-09-30 | 30-day Notice |
| S064 | 2019-09-09 | 30-day Notice |
| S063 | ||
| S062 | 2019-07-15 | 30-day Notice |
| S061 | 2019-07-05 | 30-day Notice |
| S060 | 2019-07-03 | 30-day Notice |
| S059 | 2019-06-24 | 30-day Notice |
| S058 | 2019-06-14 | 30-day Notice |
| S057 | ||
| S056 | 2019-04-19 | 30-day Notice |
| S055 | 2019-04-17 | 30-day Notice |
| S054 | 2019-03-14 | 30-day Notice |
| S053 | 2019-03-14 | Real-time Process |
| S052 | ||
| S051 | 2018-11-08 | Special (immediate Track) |
| S050 | 2018-10-09 | Special (immediate Track) |
| S049 | 2018-09-25 | Real-time Process |
| S048 | 2018-09-20 | 30-day Notice |
| S047 | 2018-05-25 | Normal 180 Day Track |
| S046 | 2018-01-31 | Special (immediate Track) |
| S045 | ||
| S044 | 2017-06-12 | 30-day Notice |
| S043 | 2017-03-03 | 30-day Notice |
| S042 | 2016-09-27 | 30-day Notice |
| S041 | 2016-09-27 | 30-day Notice |
| S040 | 2016-09-02 | 30-day Notice |
| S039 | 2016-08-26 | Special (immediate Track) |
| S038 | 2016-06-08 | 30-day Notice |
| S037 | 2016-05-20 | 30-day Notice |
| S036 | 2016-02-08 | Normal 180 Day Track |
| S035 | 2015-10-28 | 30-day Notice |
| S034 | 2015-05-05 | 30-day Notice |
| S033 | 2014-07-07 | Real-time Process |
| S032 | 2013-08-15 | 30-day Notice |
| S031 | 2013-03-22 | 30-day Notice |
| S030 | 2012-03-09 | Real-time Process |
| S029 | 2011-11-18 | 30-day Notice |
| S028 | 2011-08-15 | 30-day Notice |
| S027 | 2011-02-01 | 30-day Notice |
| S026 | 2010-07-21 | Real-time Process |
| S025 | 2010-01-07 | 30-day Notice |
| S024 | ||
| S023 | 2008-04-04 | Normal 180 Day Track No User Fee |
| S022 | ||
| S021 | 2006-09-18 | 30-day Notice |
| S020 | 2005-06-24 | Normal 180 Day Track No User Fee |
| S019 | 2003-08-26 | Normal 180 Day Track No User Fee |
| S018 | 2003-07-25 | Real-time Process |
| S017 | 1998-08-28 | Normal 180 Day Track |
| S016 | 1996-03-04 | Real-time Process |
| S015 | 1995-09-01 | Normal 180 Day Track |
| S014 | 1995-04-11 | Normal 180 Day Track |
| S013 | 1993-09-15 | Normal 180 Day Track |
| S012 | 1993-04-28 | Normal 180 Day Track |
| S011 | 1989-06-16 | Normal 180 Day Track |
| S010 | 1989-03-13 | Normal 180 Day Track |
| S009 | ||
| S008 | 1987-07-31 | Normal 180 Day Track |
| S007 | 1987-03-19 | Normal 180 Day Track |
| S006 | 1986-03-13 | |
| S005 | 1982-03-29 | |
| S004 | ||
| S003 | 1981-08-11 | |
| S002 | 1980-11-18 | |
| S001 | 1979-06-27 |
| Device ID | PMA | Supp |
|---|---|---|
| 30705031468089 | N12159 | 000 |
| 20705031002965 | N12159 | 000 |
| 20705031002958 | N12159 | 000 |
| 30705031468133 | N12159 | 000 |
| 30705031468126 | N12159 | 000 |
| 30705031468119 | N12159 | 000 |
| 30705031468102 | N12159 | 000 |
| 30705031468096 | N12159 | 000 |
| 20705031003030 | N12159 | 014 |
| 20705031003023 | N12159 | 014 |
| 20705031003016 | N12159 | 014 |
| 20705031002972 | N12159 | 014 |
| 20705031002996 | N12159 | 014 |
| 10705031002975 | N12159 | 014 |
| 20705031003061 | N12159 | 014 |
| 20705031003115 | N12159 | 015 |
| 20705031003122 | N12159 | 015 |
| 20705031003139 | N12159 | 015 |
| 20705031063584 | N12159 | 026 |
| 20705031063591 | N12159 | 027 |
| 20705031063607 | N12159 | 028 |
| 20705031063638 | N12159 | 032 |
| 20705031063621 | N12159 | 032 |
| 20705031063614 | N12159 | 032 |
| 20705031005201 | N12159 | 032 |
| 20705031005195 | N12159 | 032 |
| 20705031005362 | N12159 | 032 |
| 20705031005218 | N12159 | 032 |
| 20705031005355 | N12159 | 032 |
| 20705031237510 | N12159 | 047 |