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 | SOLESTA Injectable Gel |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Palette Life Sciences27 East Cota Streetsuite 402santa Barbara, CA 93101 PMA NumberP100014 Supplement NumberS032 Date Received09/07/2021 Decision Date03/22/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2021-09-07 |
| Decision Date | 2022-03-22 |
| PMA | P100014 |
| Supplement | S032 |
| 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 PMA NumberP100014 Supplement NumberS032 Date Received09/07/2021 Decision Date03/22/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A New Alternate Contract Sterility Testing Laboratory For The DEFLUX Injectable Gel And The Solestra Injectable Gel. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00365649850035 | P100014 | 014 |
| 00850004725016 | P100014 | 021 |