The device is indicated in surgical procedures (other than in neurosurgical, ophthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Device | FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT |
| Classification Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | BAXTER HEALTHCARE CORP. |
| Date Received | 1999-02-22 |
| Decision Date | 1999-12-08 |
| Notice Date | 1999-12-08 |
| PMA | P990009 |
| Supplement | S |
| Product Code | PMX |
| Docket Number | 00M-1229 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BAXTER HEALTHCARE CORP. 32650 N Wilson Rd round Lake, IL 60073 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| 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