Replacement of the current wet processing dispersion tanks #3 and #4, located in the 105 morgan lane medical manufacturing suite room 407, used to produce collagen dispersions for medical devices. Both of these tanks will be replaced by wet processing dispersion tanks #6 and #5, respectively. Both tanks are fabricated by the same vendor and according to the same specifications and drawings as the existing tank.
| Device | COLLASTAT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2016-02-19 |
| Decision Date | 2016-03-17 |
| PMA | P810006 |
| Supplement | S070 |
| 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