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 and 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 NumberS100 Date Received04/20/2022 Decision Date05/20/2022 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 | 2022-04-20 |
| Decision Date | 2022-05-20 |
| PMA | P900033 |
| Supplement | S100 |
| 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 NumberS100 Date Received04/20/2022 Decision Date05/20/2022 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 Replacement Of The Current Two (2) Modules Of The Water Purification (RODEI) System With Four (4) Like-in-kind Modules From The Same Manufacturer To Increase Purified Water Capacity At The Integra NeuroSciences Manufacturing Facility Located At Road 402 North, Km 1.2 Añasco, PR 00610. |
| 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 |