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.
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 | COLLACOTE(TM) COLLATAPE(R) ABSORBABLE COLLEGAGEN WOUND DRESSINGS |
| Classification Name | Material, Dressing, Surgical, Polylactic Acid |
| Generic Name | Material, Dressing, Surgical, Polylactic Acid |
| Applicant | INTEGRA LIFESCIENCES CORP. |
| Date Received | 2016-08-19 |
| Decision Date | 2016-09-15 |
| PMA | P840062 |
| Supplement | S057 |
| Product Code | LPG |
| Advisory Committee | Dental |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORP. 311 Enterprise Dr. plainsboro, NJ 08536 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840062 | Original Filing | |
| S086 | 2022-06-06 | 30-day Notice |
| S085 | 2022-04-20 | 30-day Notice |
| S084 | 2022-04-04 | 30-day Notice |
| S083 | 2021-07-16 | 30-day Notice |
| S082 | ||
| S081 | ||
| S080 | ||
| S079 | 2021-01-27 | 30-day Notice |
| S078 | 2020-12-23 | 30-day Notice |
| S077 | 2020-10-19 | 30-day Notice |
| S076 | 2019-05-28 | 30-day Notice |
| S075 | 2019-04-08 | 30-day Notice |
| S074 | 2019-04-08 | 30-day Notice |
| S073 | 2019-03-27 | 30-day Notice |
| S072 | 2019-03-21 | 30-day Notice |
| S071 | 2019-02-13 | 30-day Notice |
| S070 | 2018-10-31 | 30-day Notice |
| S069 | ||
| S068 | 2018-08-27 | Normal 180 Day Track No User Fee |
| S067 | 2018-05-01 | Normal 180 Day Track No User Fee |
| S066 | 2018-04-20 | 30-day Notice |
| S065 | 2018-03-26 | 30-day Notice |
| S064 | 2018-01-11 | 30-day Notice |
| S063 | 2017-12-22 | 135 Review Track For 30-day Notice |
| S062 | 2017-03-31 | 30-day Notice |
| S061 | 2017-01-30 | 30-day Notice |
| S060 | 2017-01-17 | 30-day Notice |
| S059 | 2016-12-21 | 30-day Notice |
| S058 | 2016-11-07 | 30-day Notice |
| S057 | 2016-08-19 | 30-day Notice |
| S056 | 2016-02-26 | 135 Review Track For 30-day Notice |
| S055 | 2016-02-19 | 30-day Notice |
| S054 | 2015-12-28 | 30-day Notice |
| S053 | ||
| S052 | 2015-08-24 | 135 Review Track For 30-day Notice |
| S051 | ||
| S050 | ||
| S049 | 2015-03-30 | 30-day Notice |
| S048 | 2015-03-23 | 30-day Notice |
| S047 | 2015-03-20 | 30-day Notice |
| S046 | 2015-03-18 | 30-day Notice |
| S045 | 2015-03-02 | 30-day Notice |
| S044 | 2015-02-24 | 30-day Notice |
| S043 | 2014-09-22 | 30-day Notice |
| S042 | 2014-09-15 | 30-day Notice |
| S041 | ||
| S040 | 2014-04-11 | 135 Review Track For 30-day Notice |
| S039 | 2014-04-10 | 30-day Notice |
| S038 | 2014-04-10 | 30-day Notice |
| S037 | 2013-12-20 | 30-day Notice |
| S036 | 2013-11-06 | 135 Review Track For 30-day Notice |
| S035 | 2013-11-01 | 135 Review Track For 30-day Notice |
| S034 | 2013-08-14 | 135 Review Track For 30-day Notice |
| S033 | 2013-08-05 | 135 Review Track For 30-day Notice |
| S032 | 2013-08-01 | 30-day Notice |
| S031 | 2013-07-31 | 30-day Notice |
| S030 | 2013-05-28 | 30-day Notice |
| S029 | 2013-05-21 | 30-day Notice |
| S028 | 2013-05-16 | 30-day Notice |
| S027 | 2013-05-15 | 30-day Notice |
| S026 | 2013-05-14 | 30-day Notice |
| S025 | 2013-05-01 | 135 Review Track For 30-day Notice |
| S024 | 2012-08-31 | 30-day Notice |
| S023 | 2012-08-23 | 30-day Notice |
| S022 | 2011-08-18 | Normal 180 Day Track No User Fee |
| S021 | 2010-08-27 | Normal 180 Day Track No User Fee |
| S020 | 2010-05-24 | 30-day Notice |
| S019 | 2009-03-09 | Normal 180 Day Track No User Fee |
| S018 | 2009-02-02 | Normal 180 Day Track No User Fee |
| S017 | 2008-03-17 | 30-day Notice |
| S016 | 2007-10-01 | 30-day Notice |
| S015 | 2007-09-05 | 30-day Notice |
| S014 | 2007-07-26 | Normal 180 Day Track No User Fee |
| S013 | 2007-06-22 | 30-day Notice |
| S012 | 2007-01-12 | 30-day Notice |
| S011 | 2006-10-11 | 30-day Notice |
| S010 | 2005-12-06 | 30-day Notice |
| S009 | 2005-09-30 | Normal 180 Day Track No User Fee |
| S008 | 2003-04-16 | 30-day Notice |
| S007 | 2000-08-18 | Normal 180 Day Track |
| S006 | 1995-07-25 | Normal 180 Day Track |
| S005 | ||
| S004 | 1992-10-26 | Normal 180 Day Track |
| S003 | 1991-10-17 | Normal 180 Day Track |
| S002 | 1990-02-23 | Normal 180 Day Track |
| S001 | 1985-11-27 | Normal 180 Day Track |