This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS102 Date Received06/07/2022 Decision Date07/01/2022 Product Code MGR Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-07 |
| Decision Date | 2022-07-01 |
| PMA | P900033 |
| Supplement | S102 |
| 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 PMA NumberP900033 Supplement NumberS102 Date Received06/07/2022 Decision Date07/01/2022 Product Code MGR Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement The Change Is To The Lyophilization Software To Ensure It Returns Data Values In Daylight Savings Time, Tol Ensure Thatdata Points Are Properly Reported With The Actual Time The Value Occurred. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| M269320211 | P900033 | 011 |
| M269381051 | P900033 | 011 |
| M269341051 | P900033 | 011 |
| M269381011 | P900033 | 011 |
| M269341011 | P900033 | 011 |
| M269340551 | P900033 | 011 |
| M269340511 | P900033 | 011 |
| M269320251 | P900033 | 011 |
| M269MDRT81011 | P900033 | 033 |
| M269MDRT40511 | P900033 | 033 |
| M269MDRT20211 | P900033 | 033 |
| M269MDRT41011 | P900033 | 033 |
| 10381780125747 | P900033 | 042 |
| 10381780125785 | P900033 | 042 |
| 10381780125754 | P900033 | 053 |
| 10381780125792 | P900033 | 053 |
| 10381780258872 | P900033 | 058 |
| 10381780258889 | P900033 | 058 |