Addition of filling/ folding stations. The production capacity of the room increased to allowing 36 operators to perform the existing process at the same time. The above change is located at room 217 in puits godet20, neochatel ch-2000, switzerland.
| Device | SURGICEL FAMILY OF ABSORBABLE HEMOSTATS |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2016-09-27 |
| Decision Date | 2016-10-24 |
| PMA | N12159 |
| Supplement | S041 |
| Product Code | LMG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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