Mechanical and system upgrades on the automated foiling line g11719 for the inspection of hermetically sealed surgicel original foil pouches to add cameras to image the bottom of the foil pouch and a modification of the vision conveyor to accommodate the added cameras
| Device | SURGICEL Original Absorbable Hemostat |
| Classification Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2019-09-09 |
| Decision Date | 2019-10-08 |
| PMA | N12159 |
| Supplement | S064 |
| 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