Splitting an existing clean compressed air (cca) point of use (pou) within room 105. You split the existing pou into two (2) pous with one pou dedicated to filter integrity testing and the other pou dedicated to equipment drying.
| Device | Helistat and 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 | 2019-03-27 |
| Decision Date | 2019-04-26 |
| PMA | P850010 |
| Supplement | S086 |
| 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