Create a new procedure, cutting and inspection procedure - acs, for the cutting and inspection of absorbable collagen sponge (acs)-(eu) used as a component of the inductos marketed in the european union (eu) product in room 304, 105 morgan lane, plainsboro, new jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, packaging of acs sponge 3”x 4” or 1”x 2” 6-pack or 1”x 2” 2-packs on the belco sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging.
| Device | COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2016-05-25 |
| Decision Date | 2016-06-22 |
| PMA | P810006 |
| Supplement | S072 |
| Product Code | LMF |
| 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 | INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P810006 | | Original Filing |
| S101 |
2022-11-21 |
30-day Notice |
| S100 |
2022-06-06 |
30-day Notice |
| S099 |
2022-04-20 |
30-day Notice |
| S098 |
2022-04-04 |
30-day Notice |
| S097 |
2021-07-16 |
30-day Notice |
| S096 | | |
| S095 | | |
| S094 |
2021-01-27 |
30-day Notice |
| S093 |
2021-01-07 |
30-day Notice |
| S092 |
2020-12-23 |
30-day Notice |
| S091 |
2020-10-19 |
30-day Notice |
| S090 |
2020-08-05 |
30-day Notice |
| S089 |
2019-05-28 |
30-day Notice |
| S088 |
2019-04-08 |
30-day Notice |
| S087 |
2019-04-08 |
30-day Notice |
| S086 |
2019-03-27 |
30-day Notice |
| S085 |
2019-03-21 |
30-day Notice |
| S084 |
2019-02-13 |
30-day Notice |
| S083 | | |
| S082 |
2018-04-20 |
30-day Notice |
| S081 |
2018-03-26 |
30-day Notice |
| S080 |
2018-01-11 |
30-day Notice |
| S079 |
2017-12-22 |
135 Review Track For 30-day Notice |
| S078 |
2017-09-29 |
30-day Notice |
| S077 |
2017-08-02 |
30-day Notice |
| S076 |
2017-03-31 |
30-day Notice |
| S075 |
2017-01-30 |
30-day Notice |
| S074 |
2016-11-07 |
30-day Notice |
| S073 |
2016-08-19 |
30-day Notice |
| S072 |
2016-05-25 |
30-day Notice |
| S071 |
2016-02-26 |
135 Review Track For 30-day Notice |
| S070 |
2016-02-19 |
30-day Notice |
| S069 | | |
| S068 |
2015-08-24 |
135 Review Track For 30-day Notice |
| S067 | | |
| S066 | | |
| S065 |
2015-03-30 |
30-day Notice |
| S064 |
2015-03-23 |
30-day Notice |
| S063 |
2015-03-20 |
30-day Notice |
| S062 |
2015-03-18 |
30-day Notice |
| S061 |
2015-03-02 |
30-day Notice |
| S060 |
2015-02-24 |
30-day Notice |
| S059 |
2015-02-18 |
30-day Notice |
| S058 |
2014-11-20 |
30-day Notice |
| S057 |
2014-10-21 |
30-day Notice |
| S056 |
2014-09-22 |
30-day Notice |
| S055 |
2014-09-15 |
30-day Notice |
| S054 | | |
| S053 |
2014-04-11 |
135 Review Track For 30-day Notice |
| S052 |
2014-04-10 |
30-day Notice |
| S051 |
2014-04-10 |
30-day Notice |
| S050 |
2013-12-20 |
30-day Notice |
| S049 |
2013-11-06 |
135 Review Track For 30-day Notice |
| S048 |
2013-11-01 |
135 Review Track For 30-day Notice |
| S047 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S046 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S045 |
2013-08-01 |
30-day Notice |
| S044 |
2013-07-31 |
30-day Notice |
| S043 |
2013-05-28 |
30-day Notice |
| S042 |
2013-05-23 |
30-day Notice |
| S041 |
2013-05-22 |
30-day Notice |
| S040 |
2013-05-21 |
30-day Notice |
| S039 |
2013-05-16 |
30-day Notice |
| S038 |
2013-05-15 |
30-day Notice |
| S037 |
2013-05-14 |
30-day Notice |
| S036 |
2013-05-01 |
135 Review Track For 30-day Notice |
| S035 |
2012-08-31 |
30-day Notice |
| S034 |
2012-08-23 |
30-day Notice |
| S033 |
2010-05-24 |
30-day Notice |
| S032 |
2009-02-02 |
Normal 180 Day Track No User Fee |
| S031 |
2008-03-17 |
30-day Notice |
| S030 |
2007-10-01 |
30-day Notice |
| S029 |
2007-09-05 |
30-day Notice |
| S028 |
2007-06-22 |
30-day Notice |
| S027 |
2007-01-12 |
30-day Notice |
| S026 |
2006-12-12 |
30-day Notice |
| S025 |
2006-11-28 |
30-day Notice |
| S024 |
2006-10-11 |
30-day Notice |
| S023 |
2005-12-06 |
30-day Notice |
| S022 |
2005-09-30 |
Normal 180 Day Track No User Fee |
| S021 |
2003-04-11 |
30-day Notice |
| S020 |
2001-06-08 |
Real-time Process |
| S019 |
1995-07-26 |
Normal 180 Day Track |
| S018 |
1993-06-18 |
Normal 180 Day Track |
| S017 |
1993-03-11 |
Normal 180 Day Track |
| S016 |
1992-06-24 |
Normal 180 Day Track |
| S015 | | |
| S014 | | |
| S013 |
1991-05-20 |
Normal 180 Day Track |
| S012 |
1989-04-24 |
Normal 180 Day Track |
| S011 |
1988-12-29 |
Normal 180 Day Track |
| S010 | | |
| S009 |
1988-10-17 |
Normal 180 Day Track |
| S008 |
1985-09-06 |
|
| S007 |
1985-03-05 |
|
| S006 |
1984-05-22 |
|
| S005 |
1983-08-19 |
|
| S004 | | |
| S003 |
1983-05-09 |
|
| S002 |
1982-02-11 |
|
| S001 |
1982-01-27 |
|
NIH GUDID Devices