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.
Acknowledge integras revisions to integras lifesciences standard operating procedure (sop) qtm-10-007 - design output variable, and manufacturing control quality assurance levels, to align with the recently updated iso 14971:2012 medical devices - application of risk management to medical devices.
| Device | COLLACOTE(TM) 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 | 2017-01-30 |
| Decision Date | 2017-03-01 |
| PMA | P840062 |
| Supplement | S061 |
| 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 |