DEFLUX INJECTABLE GEL

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P000029

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for deflux injectable gel. The device is indicated for treatment of children with vesicoureteral reflux (vur) grades ii-iv.

• Device: DEFLUX INJECTABLE GEL
• Classification Name: Agent, Bulking, Injectable For Gastro-urology Use
• Generic Name: Agent, Bulking, Injectable For Gastro-urology Use
• Applicant: Palette Life Sciences
• Date Received: 2000-07-11
• Decision Date: 2001-09-24
• Notice Date: 2001-10-01
• PMA: P000029
• Supplement: S
• Product Code: LNM
• Docket Number: 01M-0439
• Advisory Committee: Gastroenterology/Urology
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: Palette Life Sciences 27 East Cota Street suite 402 santa Barbara, CA 93101
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P000029		Original Filing
S095	2022-02-17	30-day Notice
S094
S093	2020-12-04	30-day Notice
S092	2020-11-13	30-day Notice
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 ID	PMA	Supp
00365649922039	P000029	075
00850004725023	P000029	084
00850004725009	P000029	084