Approval for labeling changes including updated graphics, instructions for use, and language translations. The device, as modified, will be marketed under the trade name surgicel snow absorbable hemostat and is indicated for: surgicel absorbable hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control arc impractical or ineffective. Surgicel original, surgicel fibrillar, surgicel nuknit and surgicel snow hemostats can be cut to size for use in endoscopic procedures. Surgicel absorbable hemostat (oxidized regenerated cellulose) is indicated for adjunctive use to assist in the control of bleeding in exodontia and oral surgery. It may also be used to help achieve hemostasis after single or multiple tooth extractions, alveoloplasty, gingival hemorrhage, impactions, biopsies, and other procedures in the oral cavity.
| Device | SURGICAL SNOW ABSORBABLE HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2012-03-09 |
| Decision Date | 2012-04-26 |
| PMA | N12159 |
| Supplement | S030 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| 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 |
Supplemental Filings
| 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 |
|
NIH GUDID Devices