Floseal Hemostatic Matrix

FDA Premarket Approval P990009 S063

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

Addition of a previously approved packaging configuration for the 5ml and 10ml floseal hemostatic matrix (floseal) device to be used with floseal “fast prep”

DeviceFloseal Hemostatic Matrix
Generic NameAbsorbable Collagen Hemostatic Agent With Thrombin
ApplicantBAXTER HEALTHCARE CORP.
Date Received2020-08-19
Decision Date2020-08-28
PMAP990009
SupplementS063
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
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

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

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