Expansion of the controlled manufacturing environment (cme) in the ethicon, llc, san lorenzo, puerto rico facility.
| Device | SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2021-08-02 |
| Decision Date | 2021-08-31 |
| PMA | N12159 |
| Supplement | S082 |
| 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