Deflux Injectable Gel

FDA Premarket Approval P000029 S090

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

Multiple changes to the water for injection (wfi) system and the compressed air system

DeviceDeflux Injectable Gel
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantPalette Life Sciences
Date Received2020-10-14
Decision Date2020-11-12
PMAP000029
SupplementS090
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Palette Life Sciences 27 East Cota Street suite 402 santa Barbara, CA 93101

Supplemental Filings

Supplement NumberDateSupplement Type
P000029Original Filing
S091 2020-10-21 30-day Notice
S090 2020-10-14 30-day Notice
S089 2020-06-09 30-day Notice
S088 2020-01-29 30-day Notice
S087
S086 2019-11-21 30-day Notice
S085 2019-08-16 30-day Notice
S084 2018-08-16 30-day Notice
S083 2018-04-26 135 Review Track For 30-day Notice
S082 2016-12-19 30-day Notice
S081 2016-09-12 135 Review Track For 30-day Notice
S080 2015-03-03 Normal 180 Day Track No User Fee
S079 2014-09-10 30-day Notice
S078 2014-07-03 30-day Notice
S077 2014-04-21 30-day Notice
S076 2013-11-25 135 Review Track For 30-day Notice
S075 2013-07-19 Normal 180 Day Track
S074 2013-04-25 Special (immediate Track)
S073 2012-11-20 30-day Notice
S072 2012-03-30 30-day Notice
S071 2012-03-23 30-day Notice
S070 2011-08-12 30-day Notice
S069 2011-06-22 30-day Notice
S068
S067 2010-03-01 Normal 180 Day Track
S066 2010-02-26 135 Review Track For 30-day Notice
S065 2010-02-22 Normal 180 Day Track
S064 2010-02-16 30-day Notice
S063 2010-01-25 30-day Notice
S062 2009-12-22 30-day Notice
S061 2009-11-10 30-day Notice
S060 2009-11-03 30-day Notice
S059 2009-09-30 30-day Notice
S058 2009-09-30 30-day Notice
S057 2009-09-30 30-day Notice
S056 2009-04-27 30-day Notice
S055 2009-04-06 30-day Notice
S054
S053 2008-12-16 30-day Notice
S052 2008-11-13 30-day Notice
S051 2008-10-06 Special (immediate Track)
S050 2008-09-19 135 Review Track For 30-day Notice
S049 2008-08-18 Special (immediate Track)
S048
S047 2008-06-13 30-day Notice
S046 2008-05-27 Special (immediate Track)
S045 2008-05-20 Special (immediate Track)
S044 2008-04-25 30-day Notice
S043 2008-03-31 30-day Notice
S042 2008-03-13 135 Review Track For 30-day Notice
S041 2008-03-10 30-day Notice
S040 2008-03-10 30-day Notice
S039 2008-02-11 30-day Notice
S038
S037 2008-02-08 30-day Notice
S036 2008-01-17 30-day Notice
S035 2008-01-15 30-day Notice
S034 2007-05-30 135 Review Track For 30-day Notice
S033 2007-05-29 30-day Notice
S032 2007-05-17 135 Review Track For 30-day Notice
S031 2007-05-09 30-day Notice
S030 2007-04-09 30-day Notice
S029 2007-03-26 30-day Notice
S028 2007-03-26 30-day Notice
S027 2007-06-11 30-day Notice
S026 2007-03-26 30-day Notice
S025 2007-03-23 30-day Notice
S024 2007-03-23 30-day Notice
S023 2007-03-23 135 Review Track For 30-day Notice
S022 2007-03-23 135 Review Track For 30-day Notice
S021 2007-03-05 Normal 180 Day Track
S020 2006-12-14 Normal 180 Day Track
S019 2006-09-05 135 Review Track For 30-day Notice
S018 2006-07-03 Special (immediate Track)
S017 2006-03-06 Normal 180 Day Track No User Fee
S016 2006-02-08 Special (immediate Track)
S015 2005-10-11 30-day Notice
S014 2005-10-06 30-day Notice
S013 2005-06-06 135 Review Track For 30-day Notice
S012 2005-04-08 Normal 180 Day Track No User Fee
S011 2004-10-28 Real-time Process
S010 2004-09-22 Real-time Process
S009 2004-07-13 30-day Notice
S008 2004-06-17 30-day Notice
S007 2004-03-23 30-day Notice
S006 2004-02-12 30-day Notice
S005 2003-12-18 30-day Notice
S004
S003 2002-12-03 Real-time Process
S002 2002-11-22 30-day Notice
S001 2002-09-10 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00365649922039 P000029 075
00850004725023 P000029 084
00850004725009 P000029 084

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