Approval for the integra omnigraft dermal regeneration matrix (a. K. A. Omnigraft) and integra dermal regeneration template. Integra omnigraft dermal regeneration matrix is indicated for use in the treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care and integra dermal regeneration template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient; 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; and treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.
| Device | INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO |
| Classification Name | Device, Dermal Replacement |
| Generic Name | Device, Dermal Replacement |
| Applicant | Integra LifeSciences Corp. |
| Date Received | 2015-01-29 |
| Decision Date | 2016-01-07 |
| Notice Date | 2016-01-11 |
| PMA | P900033 |
| Supplement | S042 |
| Product Code | MDD |
| Docket Number | 16M-0121 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Integra LifeSciences Corp. 105 Morgan Ln. plainsboro, NJ 08536 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
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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