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.
| Device | Helistat® and Helitene® Absorbable Collagen Hemostatic Agents |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS104 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-21 |
| Decision Date | 2022-12-19 |
| PMA | P850010 |
| Supplement | S104 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS104 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement For The Environmental Monitoring Process Qualification Of Room 307, At The Collagen Manufacturing Center (CMC) Located At 105 Morgan Lane, Plainsboro, NJ 08536. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850010 | Original Filing | |
| S104 | 2022-11-21 | 30-day Notice |
| S103 | 2022-06-06 | 30-day Notice |
| S102 | 2022-04-20 | 30-day Notice |
| S101 | 2022-04-04 | 30-day Notice |
| S100 | 2022-03-21 | 30-day Notice |
| S099 | 2021-07-16 | 30-day Notice |
| S098 | ||
| S097 | ||
| S096 | 2021-03-31 | 30-day Notice |
| S095 | ||
| S094 | 2021-01-27 | 30-day Notice |
| S093 | 2021-01-07 | 30-day Notice |
| S092 | 2020-12-23 | 30-day Notice |
| S091 | 2020-10-19 | 30-day Notice |
| S090 | 2020-08-05 | 30-day Notice |
| S089 | 2019-05-28 | 30-day Notice |
| S088 | 2019-04-08 | 30-day Notice |
| S087 | 2019-04-08 | 30-day Notice |
| S086 | 2019-03-27 | 30-day Notice |
| S085 | 2019-03-21 | 30-day Notice |
| S084 | 2019-02-13 | 30-day Notice |
| S083 | ||
| S082 | 2018-09-14 | Normal 180 Day Track No User Fee |
| S081 | 2018-04-20 | 30-day Notice |
| S080 | 2018-03-26 | 30-day Notice |
| S079 | 2018-01-11 | 30-day Notice |
| S078 | 2017-12-22 | 135 Review Track For 30-day Notice |
| S077 | 2017-09-29 | 30-day Notice |
| S076 | 2017-08-02 | 30-day Notice |
| S075 | 2017-03-31 | 30-day Notice |
| S074 | 2017-01-30 | 30-day Notice |
| S073 | 2016-11-07 | 30-day Notice |
| S072 | 2016-08-19 | 30-day Notice |
| S071 | 2016-05-25 | 30-day Notice |
| S070 | 2016-02-26 | 135 Review Track For 30-day Notice |
| S069 | 2016-02-19 | 30-day Notice |
| S068 | ||
| S067 | 2015-08-24 | 135 Review Track For 30-day Notice |
| S066 | ||
| S065 | ||
| S064 | 2015-03-30 | 30-day Notice |
| S063 | 2015-03-23 | 30-day Notice |
| S062 | 2015-03-20 | 30-day Notice |
| S061 | 2015-03-18 | 30-day Notice |
| S060 | 2015-03-02 | 30-day Notice |
| S059 | 2015-02-24 | 30-day Notice |
| S058 | 2015-02-18 | 30-day Notice |
| S057 | 2014-11-20 | 30-day Notice |
| S056 | 2014-09-22 | 30-day Notice |
| S055 | 2014-09-15 | 30-day Notice |
| S054 | ||
| S053 | 2014-04-11 | 135 Review Track For 30-day Notice |
| S052 | 2014-04-10 | 30-day Notice |
| S051 | 2014-04-10 | 30-day Notice |
| S050 | 2014-03-26 | 30-day Notice |
| S049 | 2013-12-20 | 30-day Notice |
| S048 | 2013-11-21 | 30-day Notice |
| S047 | 2013-11-06 | 135 Review Track For 30-day Notice |
| S046 | 2013-11-01 | 135 Review Track For 30-day Notice |
| S045 | 2013-08-14 | 135 Review Track For 30-day Notice |
| S044 | 2013-08-14 | 135 Review Track For 30-day Notice |
| S043 | 2013-08-01 | 30-day Notice |
| S042 | 2013-07-31 | 30-day Notice |
| S041 | 2013-05-28 | 30-day Notice |
| S040 | 2013-05-22 | 30-day Notice |
| S039 | 2013-05-21 | 30-day Notice |
| S038 | 2013-05-20 | 30-day Notice |
| S037 | 2013-05-20 | 30-day Notice |
| S036 | 2013-05-16 | 30-day Notice |
| S035 | 2013-05-15 | 30-day Notice |
| S034 | 2013-05-14 | 30-day Notice |
| S033 | 2013-05-01 | 135 Review Track For 30-day Notice |
| S032 | 2012-08-31 | 30-day Notice |
| S031 | 2012-08-23 | 30-day Notice |
| S030 | 2010-05-24 | 30-day Notice |
| S029 | 2009-02-02 | Normal 180 Day Track No User Fee |
| S028 | 2008-03-17 | 30-day Notice |
| S027 | 2007-10-01 | 30-day Notice |
| S026 | 2007-09-05 | 30-day Notice |
| S025 | 2007-06-22 | 30-day Notice |
| S024 | 2007-01-12 | 30-day Notice |
| S023 | 2006-12-12 | 30-day Notice |
| S022 | 2006-11-28 | 30-day Notice |
| S021 | 2006-10-11 | 30-day Notice |
| S020 | 2005-12-06 | 30-day Notice |
| S019 | 2005-09-30 | Normal 180 Day Track No User Fee |
| S018 | 2003-04-15 | 30-day Notice |
| S017 | 2002-03-15 | Real-time Process |
| S016 | 2001-06-08 | Real-time Process |
| S015 | 1995-07-26 | Normal 180 Day Track |
| S014 | 1992-07-06 | Normal 180 Day Track |
| S013 | 1991-10-18 | Normal 180 Day Track |
| S012 | 1990-02-23 | Normal 180 Day Track |
| S011 | 1990-01-22 | Normal 180 Day Track |
| S010 | 1988-12-23 | Normal 180 Day Track |
| S009 | ||
| S008 | ||
| S007 | 1987-01-02 | Normal 180 Day Track |
| S006 | 1987-01-27 | Normal 180 Day Track |
| S005 | 1987-01-12 | Normal 180 Day Track |
| S004 | 1986-08-20 | Normal 180 Day Track |
| S003 | 1986-08-20 | Normal 180 Day Track |
| S002 | 1986-06-19 | 30-Day Supplement |
| S001 | 1985-12-13 |
| Device ID | PMA | Supp |
|---|---|---|
| 10381780000204 | P850010 | 000 |
| 10381780000228 | P850010 | 005 |
| 10381780000211 | P850010 | 005 |
| 10381780000198 | P850010 | 007 |
| 10381780508656 | P850010 | 007 |
| 10381780000228 | P850010 | 011 |
| 10381780000211 | P850010 | 011 |