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.
Increase in the sample size for bacterial endotoxin testing (bet) for all collagen products manufactured at the plainsboro new jersey facility and at the anasco, puerto rico location.
| Device | COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY |
| Classification Name | Material, Dressing, Surgical, Polylactic Acid |
| Generic Name | Material, Dressing, Surgical, Polylactic Acid |
| Applicant | INTEGRA LIFESCIENCES CORP. |
| Date Received | 2013-07-31 |
| Decision Date | 2013-08-29 |
| PMA | P840062 |
| Supplement | S031 |
| 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 |