Floseal Hemostatic Matrix

FDA Premarket Approval P990009 S060

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.

Pre-market Approval Supplement Details

Change of a packaging material supplier

DeviceFloseal Hemostatic Matrix
Generic NameAbsorbable Collagen Hemostatic Agent With Thrombin
ApplicantBAXTER HEALTHCARE CORP.
Date Received2020-05-04
Decision Date2020-06-02
PMAP990009
SupplementS060
Product CodePMX 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BAXTER HEALTHCARE CORP. 32650 N Wilson Rd round Lake, IL 60073

Supplemental Filings

Supplement NumberDateSupplement Type
P990009Original Filing
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

Device IDPMASupp
50085412532863 P990009 044
50085412532733 P990009 044
50085412639609 P990009 051
50085412639593 P990009 051
50085412656309 P990009 053

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