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 | INTEGRA ARTIFICAL SKIN DERMAL REGENERATION TEMPLATE |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | Integra LifeSciences Corp. |
| Date Received | 2016-08-19 |
| Decision Date | 2016-09-15 |
| PMA | P900033 |
| Supplement | S056 |
| 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