Device | COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS |
Classification Name | Material, Dressing, Surgical, Polylactic Acid |
Generic Name | Material, Dressing, Surgical, Polylactic Acid |
Applicant | INTEGRA LIFESCIENCES CORP. |
Date Received | 1991-10-17 |
Decision Date | 1992-03-27 |
PMA | P840062 |
Supplement | S003 |
Product Code | LPG |
Advisory Committee | Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
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 |