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.
Approval for the implementation of mechanical, program, and system control changes to the existing chilled water system that services collagen lyophilizer machines in the lyo manufacturing area of building 1 at the integra neurosciences facility in aÑasco, puerto rico, for the devices.
| Device | COLLACOTE,COLLATAPE,COLLAPLUG ABSORABLE COLLAGEN WOUND DRESS |
| Classification Name | Material, Dressing, Surgical, Polylactic Acid |
| Generic Name | Material, Dressing, Surgical, Polylactic Acid |
| Applicant | INTEGRA LIFESCIENCES CORP. |
| Date Received | 2014-04-11 |
| Decision Date | 2014-10-17 |
| PMA | P840062 |
| Supplement | S040 |
| Product Code | LPG |
| Advisory Committee | Dental |
| Supplement Type | 135 Review Track For 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 |