Approval for inclusion of human thrombin that has been treated with a second viral inactivation step (solvent detergent process) in the floseal hemostatic matrix kit as well as approval for associated labeling changes to reflect the additional viral inactivation step for the thrombin component.
| Device | FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | BAXTER HEALTHCARE CORP. |
| Date Received | 2009-02-26 |
| Decision Date | 2010-01-07 |
| PMA | P990009 |
| Supplement | S025 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BAXTER HEALTHCARE CORP. 32650 N Wilson Rd round Lake, IL 60073 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990009 | | Original Filing |
| S071 |
2022-10-26 |
Special (immediate Track) |
| S070 | | |
| S069 |
2022-04-22 |
30-day Notice |
| S068 |
2021-11-23 |
30-day Notice |
| S067 | | |
| S066 | | |
| S065 |
2020-11-27 |
30-day Notice |
| S064 |
2020-11-09 |
30-day Notice |
| S063 |
2020-08-19 |
30-day Notice |
| S062 |
2020-08-11 |
30-day Notice |
| S061 | | |
| S060 |
2020-05-04 |
30-day Notice |
| S059 |
2019-12-10 |
30-day Notice |
| S058 | | |
| S057 |
2019-07-01 |
30-day Notice |
| S056 | | |
| S055 | | |
| S054 |
2019-04-12 |
30-day Notice |
| S053 |
2019-01-22 |
Real-time Process |
| S052 |
2018-12-26 |
Real-time Process |
| S051 |
2018-12-04 |
Real-time Process |
| S050 |
2017-10-02 |
30-day Notice |
| S049 |
2017-08-14 |
Real-time Process |
| S048 |
2017-08-10 |
Real-time Process |
| S047 | | |
| S046 |
2017-04-17 |
30-day Notice |
| S045 |
2016-12-05 |
Special (immediate Track) |
| S044 |
2016-11-02 |
Normal 180 Day Track |
| S043 |
2016-08-19 |
Special (immediate Track) |
| S042 |
2016-06-02 |
135 Review Track For 30-day Notice |
| S041 |
2015-06-15 |
30-day Notice |
| S040 |
2015-03-19 |
Normal 180 Day Track No User Fee |
| S039 |
2014-07-25 |
Normal 180 Day Track No User Fee |
| S038 |
2013-11-25 |
30-day Notice |
| S037 |
2013-06-06 |
Normal 180 Day Track |
| S036 |
2013-05-20 |
Special (immediate Track) |
| S035 |
2013-03-25 |
Normal 180 Day Track |
| S034 |
2012-03-06 |
Real-time Process |
| S033 |
2012-03-02 |
Real-time Process |
| S032 |
2011-04-06 |
30-day Notice |
| S031 |
2011-02-14 |
30-day Notice |
| S030 |
2010-07-21 |
30-day Notice |
| S029 |
2010-03-05 |
Special (immediate Track) |
| S028 |
2010-01-27 |
30-day Notice |
| S027 |
2009-10-15 |
Real-time Process |
| S026 |
2009-04-17 |
Real-time Process |
| S025 |
2009-02-26 |
Normal 180 Day Track |
| S024 |
2008-09-22 |
30-day Notice |
| S023 |
2008-09-12 |
30-day Notice |
| S022 |
2008-02-19 |
30-day Notice |
| S021 |
2007-11-19 |
30-day Notice |
| S020 |
2007-10-31 |
30-day Notice |
| S019 |
2007-02-20 |
Real-time Process |
| S018 |
2006-02-13 |
Normal 180 Day Track No User Fee |
| S017 |
2005-12-16 |
30-day Notice |
| S016 |
2004-11-15 |
Real-time Process |
| S015 |
2003-06-13 |
30-day Notice |
| S014 |
2003-04-29 |
Normal 180 Day Track No User Fee |
| S013 |
2002-11-18 |
Normal 180 Day Track |
| S012 |
2002-06-04 |
30-day Notice |
| S011 |
2001-09-25 |
Real-time Process |
| S010 |
2001-08-31 |
Normal 180 Day Track |
| S009 |
2001-06-26 |
Real-time Process |
| S008 |
2001-06-18 |
Normal 180 Day Track |
| S007 |
2001-03-05 |
Real-time Process |
| S006 |
2001-03-02 |
Real-time Process |
| S005 |
2001-02-01 |
Real-time Process |
| S004 |
2001-01-16 |
Real-time Process |
| S003 |
2000-12-22 |
Normal 180 Day Track |
| S002 |
2000-10-24 |
Normal 180 Day Track |
| S001 |
2000-10-04 |
Real-time Process |
NIH GUDID Devices