Approval for a labeling change to delete the contraindication for deflux in duplex systems, and to replace it with a precaution.
| 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 | 2006-12-14 |
| Decision Date | 2007-04-19 |
| PMA | P000029 |
| Supplement | S020 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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