Approval for a manufacturing facility located at fusion medical technologies, inc. , fremont, california.
Device | FUSION MATRIX-DRY |
Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
Applicant | BAXTER HEALTHCARE CORP. |
Date Received | 2001-06-18 |
Decision Date | 2001-07-20 |
PMA | P990009 |
Supplement | S008 |
Product Code | LMF |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
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