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 | 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 | 2019-03-27 |
| Decision Date | 2019-04-26 |
| PMA | P900033 |
| Supplement | S078 |
| 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