Replacement of a portion of the water deionization (di) system, located in the collagen manufacturing center. Integra will replace a portion of the di system with a new evoqua ionright gen3 system. The change is being made to lower operating expenses, as well as reduce the frequency of service of the system by reducing the frequency at which the vessels are shipped off site for regeneration.
| Device | HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2016-08-19 |
| Decision Date | 2016-09-15 |
| PMA | P850010 |
| 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 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