Approval for the installation, operation and environmental monitoring validations for the addition of three hepa flow stations in the integra packaging room 304 at integra lifesciences, 105 morgan lane, plainsboro, new jersey.
| Device | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2016-02-26 |
| Decision Date | 2016-10-07 |
| PMA | P850010 |
| Supplement | S070 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 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 08540 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850010 | | Original Filing |
| S104 |
2022-11-21 |
30-day Notice |
| S103 |
2022-06-06 |
30-day Notice |
| S102 |
2022-04-20 |
30-day Notice |
| S101 |
2022-04-04 |
30-day Notice |
| S100 |
2022-03-21 |
30-day Notice |
| S099 |
2021-07-16 |
30-day Notice |
| S098 | | |
| S097 | | |
| S096 |
2021-03-31 |
30-day Notice |
| 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 |
2018-09-14 |
Normal 180 Day Track No User Fee |
| S081 |
2018-04-20 |
30-day Notice |
| S080 |
2018-03-26 |
30-day Notice |
| S079 |
2018-01-11 |
30-day Notice |
| S078 |
2017-12-22 |
135 Review Track For 30-day Notice |
| S077 |
2017-09-29 |
30-day Notice |
| S076 |
2017-08-02 |
30-day Notice |
| S075 |
2017-03-31 |
30-day Notice |
| S074 |
2017-01-30 |
30-day Notice |
| S073 |
2016-11-07 |
30-day Notice |
| S072 |
2016-08-19 |
30-day Notice |
| S071 |
2016-05-25 |
30-day Notice |
| S070 |
2016-02-26 |
135 Review Track For 30-day Notice |
| S069 |
2016-02-19 |
30-day Notice |
| S068 | | |
| S067 |
2015-08-24 |
135 Review Track For 30-day Notice |
| S066 | | |
| S065 | | |
| S064 |
2015-03-30 |
30-day Notice |
| S063 |
2015-03-23 |
30-day Notice |
| S062 |
2015-03-20 |
30-day Notice |
| S061 |
2015-03-18 |
30-day Notice |
| S060 |
2015-03-02 |
30-day Notice |
| S059 |
2015-02-24 |
30-day Notice |
| S058 |
2015-02-18 |
30-day Notice |
| S057 |
2014-11-20 |
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 |
2014-03-26 |
30-day Notice |
| S049 |
2013-12-20 |
30-day Notice |
| S048 |
2013-11-21 |
30-day Notice |
| S047 |
2013-11-06 |
135 Review Track For 30-day Notice |
| S046 |
2013-11-01 |
135 Review Track For 30-day Notice |
| S045 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S044 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S043 |
2013-08-01 |
30-day Notice |
| S042 |
2013-07-31 |
30-day Notice |
| S041 |
2013-05-28 |
30-day Notice |
| S040 |
2013-05-22 |
30-day Notice |
| S039 |
2013-05-21 |
30-day Notice |
| S038 |
2013-05-20 |
30-day Notice |
| S037 |
2013-05-20 |
30-day Notice |
| S036 |
2013-05-16 |
30-day Notice |
| S035 |
2013-05-15 |
30-day Notice |
| S034 |
2013-05-14 |
30-day Notice |
| S033 |
2013-05-01 |
135 Review Track For 30-day Notice |
| S032 |
2012-08-31 |
30-day Notice |
| S031 |
2012-08-23 |
30-day Notice |
| S030 |
2010-05-24 |
30-day Notice |
| S029 |
2009-02-02 |
Normal 180 Day Track No User Fee |
| S028 |
2008-03-17 |
30-day Notice |
| S027 |
2007-10-01 |
30-day Notice |
| S026 |
2007-09-05 |
30-day Notice |
| S025 |
2007-06-22 |
30-day Notice |
| S024 |
2007-01-12 |
30-day Notice |
| S023 |
2006-12-12 |
30-day Notice |
| S022 |
2006-11-28 |
30-day Notice |
| S021 |
2006-10-11 |
30-day Notice |
| S020 |
2005-12-06 |
30-day Notice |
| S019 |
2005-09-30 |
Normal 180 Day Track No User Fee |
| S018 |
2003-04-15 |
30-day Notice |
| S017 |
2002-03-15 |
Real-time Process |
| S016 |
2001-06-08 |
Real-time Process |
| S015 |
1995-07-26 |
Normal 180 Day Track |
| S014 |
1992-07-06 |
Normal 180 Day Track |
| S013 |
1991-10-18 |
Normal 180 Day Track |
| S012 |
1990-02-23 |
Normal 180 Day Track |
| S011 |
1990-01-22 |
Normal 180 Day Track |
| S010 |
1988-12-23 |
Normal 180 Day Track |
| S009 | | |
| S008 | | |
| S007 |
1987-01-02 |
Normal 180 Day Track |
| S006 |
1987-01-27 |
Normal 180 Day Track |
| S005 |
1987-01-12 |
Normal 180 Day Track |
| S004 |
1986-08-20 |
Normal 180 Day Track |
| S003 |
1986-08-20 |
Normal 180 Day Track |
| S002 |
1986-06-19 |
30-Day Supplement |
| S001 |
1985-12-13 |
|
NIH GUDID Devices