Qualification of two (2) new total organic carbon (toc) analyzers at the quality control (qc) analytical laboratory at the collagen manufacturing center (cmc).
| Device | Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | Integra LifeSciences Corp. |
| Date Received | 2019-04-08 |
| Decision Date | 2019-05-07 |
| PMA | P900033 |
| Supplement | S080 |
| Product Code | MGR |
| 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 Corp. 105 Morgan Ln. plainsboro, NJ 08536 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P900033 | | Original Filing |
| S103 |
2022-11-14 |
30-day Notice |
| S102 |
2022-06-07 |
30-day Notice |
| S101 | | |
| S100 |
2022-04-20 |
30-day Notice |
| S099 |
2022-04-04 |
30-day Notice |
| S098 | | |
| S097 |
2021-07-16 |
30-day Notice |
| S096 |
2021-06-09 |
30-day Notice |
| S095 | | |
| S094 | | |
| S093 |
2021-01-27 |
30-day Notice |
| S092 |
2020-12-23 |
30-day Notice |
| S091 |
2020-10-19 |
30-day Notice |
| S090 |
2020-09-17 |
30-day Notice |
| S089 |
2020-08-05 |
30-day Notice |
| S088 | | |
| S087 | | |
| S086 |
2019-08-07 |
30-day Notice |
| S085 |
2019-07-31 |
30-day Notice |
| S084 |
2019-07-30 |
30-day Notice |
| S083 |
2019-07-29 |
30-day Notice |
| S082 |
2019-07-10 |
30-day Notice |
| S081 |
2019-06-21 |
30-day Notice |
| S080 |
2019-04-08 |
30-day Notice |
| S079 |
2019-04-08 |
30-day Notice |
| S078 |
2019-03-27 |
30-day Notice |
| S077 |
2019-03-21 |
30-day Notice |
| S076 |
2019-02-13 |
30-day Notice |
| S075 |
2019-02-11 |
30-day Notice |
| S074 |
2018-08-31 |
135 Review Track For 30-day Notice |
| S073 |
2018-08-16 |
30-day Notice |
| S072 |
2018-07-12 |
30-day Notice |
| S071 |
2018-06-20 |
30-day Notice |
| S070 |
2018-04-20 |
30-day Notice |
| S069 |
2018-03-26 |
30-day Notice |
| S068 |
2018-03-07 |
30-day Notice |
| S067 |
2017-12-04 |
30-day Notice |
| S066 |
2017-10-30 |
30-day Notice |
| S065 |
2017-10-12 |
135 Review Track For 30-day Notice |
| S064 | | |
| S063 |
2017-06-29 |
Normal 180 Day Track No User Fee |
| S062 |
2017-06-12 |
30-day Notice |
| S061 |
2017-03-31 |
30-day Notice |
| S060 |
2017-01-30 |
30-day Notice |
| S059 |
2016-12-19 |
30-day Notice |
| S058 |
2016-11-15 |
Real-time Process |
| S057 |
2016-08-24 |
30-day Notice |
| S056 |
2016-08-19 |
30-day Notice |
| S055 |
2016-07-25 |
30-day Notice |
| S054 |
2015-11-24 |
Normal 180 Day Track No User Fee |
| S053 |
2015-11-03 |
Normal 180 Day Track |
| S052 | | |
| S051 |
2015-08-24 |
135 Review Track For 30-day Notice |
| S050 | | |
| S049 | | |
| S048 |
2015-06-03 |
30-day Notice |
| S047 |
2015-05-20 |
Real-time Process |
| S046 |
2015-03-23 |
30-day Notice |
| S045 |
2015-03-18 |
30-day Notice |
| S044 |
2015-03-02 |
30-day Notice |
| S043 |
2015-02-03 |
30-day Notice |
| S042 |
2015-01-29 |
Panel Track |
| S041 |
2014-09-29 |
135 Review Track For 30-day Notice |
| S040 |
2014-09-29 |
30-day Notice |
| S039 |
2014-09-22 |
30-day Notice |
| S038 |
2014-09-15 |
30-day Notice |
| S037 |
2014-06-23 |
30-day Notice |
| S036 | | |
| S035 |
2014-04-11 |
135 Review Track For 30-day Notice |
| S034 |
2014-04-10 |
30-day Notice |
| S033 |
2014-01-07 |
Real-time Process |
| S032 |
2013-11-01 |
135 Review Track For 30-day Notice |
| S031 |
2013-07-31 |
30-day Notice |
| S030 |
2013-05-28 |
30-day Notice |
| S029 |
2013-05-15 |
30-day Notice |
| S028 |
2013-05-14 |
30-day Notice |
| S027 |
2013-05-01 |
135 Review Track For 30-day Notice |
| S026 |
2013-04-26 |
135 Review Track For 30-day Notice |
| S025 |
2012-07-27 |
30-day Notice |
| S024 |
2012-07-27 |
30-day Notice |
| S023 |
2012-07-25 |
30-day Notice |
| S022 |
2012-07-23 |
30-day Notice |
| S021 |
2011-10-13 |
Normal 180 Day Track No User Fee |
| S020 |
2011-08-01 |
Normal 180 Day Track No User Fee |
| S019 |
2008-03-17 |
30-day Notice |
| S018 |
2007-10-01 |
30-day Notice |
| S017 |
2007-08-24 |
30-day Notice |
| S016 |
2007-05-14 |
30-day Notice |
| S015 |
2007-01-12 |
30-day Notice |
| S014 |
2006-10-11 |
30-day Notice |
| S013 |
2005-12-06 |
30-day Notice |
| S012 |
2004-08-23 |
30-day Notice |
| S011 |
2004-01-02 |
Real-time Process |
| S010 |
2003-11-07 |
30-day Notice |
| S009 |
2003-04-16 |
30-day Notice |
| S008 |
2001-10-26 |
Panel Track |
| S007 |
2001-07-06 |
Real-time Process |
| S006 |
2001-06-19 |
Real-time Process |
| S005 |
2001-04-13 |
Real-time Process |
| S004 | | |
| S003 |
1999-11-08 |
30-day Notice |
| S002 |
1997-06-30 |
Real-time Process |
| S001 |
1996-08-19 |
Real-time Process |
NIH GUDID Devices