Approval for labeling changes to enhance the safety of your device, including removal of the phrase spurting from bleeding types for which use of the device is described as effective in the warnings section of the labeling.
| Device | FLOSEAL HEMOSTATIC MATRIX |
| Classification Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | BAXTER HEALTHCARE CORP. |
| Date Received | 2016-08-19 |
| Decision Date | 2016-09-14 |
| PMA | P990009 |
| Supplement | S043 |
| Product Code | PMX |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BAXTER HEALTHCARE CORP. 32650 N Wilson Rd round Lake, IL 60073 |
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