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 Absoibable Collagen Hemostatic Agents |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS100 Date Received03/21/2022 Decision Date04/20/2022 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 | 2022-03-21 |
| Decision Date | 2022-04-20 |
| PMA | P850010 |
| Supplement | S100 |
| 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 NumberS100 Date Received03/21/2022 Decision Date04/20/2022 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 relocation Of The Supplier Site For Tyvek Envelope Processing |
| 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 |