Approval for a design change to the integra® dermal regenerationtemplate. The design change was to produce a meshed version of the integra® dermal regeneration template. The device, as modified, will be marketed under the trade name integra® meshed dermal regeneration template and is indicated for the post excisional treatment of life-threatening full-thickness or deep partial thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. It is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient.
| Device | INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE |
| Classification Name | Device, Dermal Replacement |
| Generic Name | Device, Dermal Replacement |
| Applicant | Integra LifeSciences Corp. |
| Date Received | 2014-01-07 |
| Decision Date | 2014-04-07 |
| PMA | P900033 |
| Supplement | S033 |
| Product Code | MDD |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
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