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.
| Device | DEFLUX Injectable Gel |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Palette Life Sciences27 East Cota Streetsuite 402santa Barbara, CA 93101 PMA NumberP000029 Supplement NumberS095 Date Received02/17/2022 Decision Date03/17/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-03-17 |
| PMA | P000029 |
| Supplement | S095 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 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 PMA NumberP000029 Supplement NumberS095 Date Received02/17/2022 Decision Date03/17/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Additional Supplier For Sodium Hydroxide Solution, Hydrochloric Acid Solution And Phosphate Buffer Concentrate |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00365649922039 | P000029 | 075 |
| 00850004725023 | P000029 | 084 |
| 00850004725009 | P000029 | 084 |