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 | SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 1995-04-11 |
| Decision Date | 1995-05-12 |
| PMA | N12159 |
| Supplement | S014 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |