Approval for the solesta. This device is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (e. G. , diet, fiber therapy, anti-motility medications).
| Device | SOLESTA 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 | 2010-04-09 |
| Decision Date | 2011-05-27 |
| Notice Date | 2011-06-15 |
| PMA | P100014 |
| Supplement | S |
| Product Code | LNM |
| Docket Number | 11M-0445 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100014 | | Original Filing |
| S033 |
2022-02-17 |
30-day Notice |
| S032 |
2021-09-07 |
135 Review Track For 30-day Notice |
| S031 |
2021-05-03 |
Normal 180 Day Track No User Fee |
| S030 |
2020-12-04 |
30-day Notice |
| S029 |
2020-11-13 |
30-day Notice |
| S028 |
2020-10-14 |
30-day Notice |
| S027 |
2020-06-09 |
30-day Notice |
| S026 | | |
| S025 |
2020-01-29 |
30-day Notice |
| S024 | | |
| S023 |
2019-11-21 |
30-day Notice |
| S022 |
2019-08-16 |
30-day Notice |
| S021 |
2018-08-16 |
30-day Notice |
| S020 |
2018-04-26 |
135 Review Track For 30-day Notice |
| S019 |
2016-12-19 |
30-day Notice |
| S018 |
2016-09-12 |
135 Review Track For 30-day Notice |
| S017 |
2014-11-19 |
Normal 180 Day Track No User Fee |
| S016 |
2014-09-10 |
30-day Notice |
| S015 |
2014-07-07 |
30-day Notice |
| S014 |
2014-06-12 |
135 Review Track For 30-day Notice |
| S013 |
2014-05-28 |
135 Review Track For 30-day Notice |
| S012 |
2013-11-26 |
135 Review Track For 30-day Notice |
| S011 |
2013-11-04 |
Normal 180 Day Track No User Fee |
| S010 | | |
| S009 |
2013-04-01 |
Normal 180 Day Track No User Fee |
| S008 |
2012-11-20 |
30-day Notice |
| S007 |
2012-03-30 |
30-day Notice |
| S006 |
2012-03-23 |
30-day Notice |
| S005 |
2012-03-20 |
Normal 180 Day Track No User Fee |
| S004 |
2011-10-13 |
Normal 180 Day Track No User Fee |
| S003 |
2011-08-15 |
30-day Notice |
| S002 |
2011-07-12 |
30-day Notice |
| S001 | | |
NIH GUDID Devices