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 | Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | BAXTER HEALTHCARE CORP.32650 N Wilson Rdround Lake, IL 60073 PMA NumberP990009 Supplement NumberS071 Date Received10/26/2022 Decision Date11/22/2022 Product Code PMX Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-10-26 |
| Decision Date | 2022-11-22 |
| PMA | P990009 |
| Supplement | S071 |
| 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 PMA NumberP990009 Supplement NumberS071 Date Received10/26/2022 Decision Date11/22/2022 Product Code PMX Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval To Add New Information To The Warnings And Adverse Events Sections Of The FLOSEAL Instructions For Use. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 50085412532863 | P990009 | 044 |
| 50085412532733 | P990009 | 044 |
| 50085412639609 | P990009 | 051 |
| 50085412639593 | P990009 | 051 |
| 50085412656309 | P990009 | 053 |
| 50085412827952 | P990009 | 067 |
| 50085412827891 | P990009 | 070 |