Approval for performing the protein testing in-house at the q-med quality control laboratory and to change the test method so as to allow for the detection of lower amounts of protein. The device, as modified, will be marketed under the trade name deflux and is indicated for the treatment of vesicoureteral reflux in children.
| Device | DEFLUX |
| Classification Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Palette Life Sciences |
| Date Received | 2005-06-06 |
| Decision Date | 2005-12-12 |
| PMA | P000029 |
| Supplement | S013 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Palette Life Sciences 27 East Cota Street suite 402 santa Barbara, CA 93101 |
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