Approval for gel-one. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (nsaids) or analgesics, e. G. , acetaminophen.
| Device | GEL-ONE(R) |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | SEIKAGAKU CORP. |
| Date Received | 2016-04-01 |
| Decision Date | 2016-09-27 |
| Notice Date | 2016-09-30 |
| PMA | P080020 |
| Supplement | S020 |
| Product Code | MOZ |
| Docket Number | 16M-2975 |
| Advisory Committee | Orthopedic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SEIKAGAKU CORP. 6-1, Marunouchi 1-chome, chiyoda-ku tokyo 100-0-0005 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080020 | | Original Filing |
| S051 |
2022-12-08 |
30-day Notice |
| S050 | | |
| S049 |
2022-09-20 |
30-day Notice |
| S048 |
2022-06-22 |
30-day Notice |
| S047 |
2022-03-03 |
30-day Notice |
| S046 |
2021-10-27 |
30-day Notice |
| S045 |
2021-09-15 |
30-day Notice |
| S044 |
2021-07-22 |
30-day Notice |
| S043 |
2021-04-29 |
30-day Notice |
| S042 |
2021-03-18 |
30-day Notice |
| S041 | | |
| S040 |
2020-10-20 |
30-day Notice |
| S039 |
2020-10-14 |
30-day Notice |
| S038 |
2020-07-01 |
30-day Notice |
| S037 |
2020-03-10 |
30-day Notice |
| S036 |
2020-02-25 |
30-day Notice |
| S035 |
2019-08-01 |
Real-time Process |
| S034 | | |
| S033 |
2019-02-07 |
30-day Notice |
| S032 |
2019-02-05 |
30-day Notice |
| S031 |
2018-11-07 |
30-day Notice |
| S030 |
2018-07-12 |
30-day Notice |
| S029 |
2018-02-14 |
30-day Notice |
| S028 |
2018-01-10 |
30-day Notice |
| S027 |
2017-11-15 |
30-day Notice |
| S026 |
2017-06-28 |
135 Review Track For 30-day Notice |
| S025 |
2017-02-23 |
30-day Notice |
| S024 |
2016-12-22 |
30-day Notice |
| S023 |
2016-11-22 |
30-day Notice |
| S022 |
2016-11-01 |
30-day Notice |
| S021 |
2016-06-30 |
30-day Notice |
| S020 |
2016-04-01 |
Panel Track |
| S019 |
2016-02-24 |
30-day Notice |
| S018 |
2015-08-31 |
Normal 180 Day Track |
| S017 |
2015-07-30 |
30-day Notice |
| S016 |
2015-07-29 |
30-day Notice |
| S015 |
2015-06-16 |
30-day Notice |
| S014 |
2015-05-05 |
Normal 180 Day Track |
| S013 |
2014-09-30 |
30-day Notice |
| S012 |
2014-07-31 |
30-day Notice |
| S011 |
2014-07-30 |
30-day Notice |
| S010 |
2014-07-29 |
30-day Notice |
| S009 |
2014-07-28 |
30-day Notice |
| S008 |
2014-06-17 |
135 Review Track For 30-day Notice |
| S007 |
2014-05-01 |
30-day Notice |
| S006 |
2013-09-13 |
30-day Notice |
| S005 |
2013-07-25 |
30-day Notice |
| S004 |
2012-11-02 |
30-day Notice |
| S003 |
2012-10-04 |
30-day Notice |
| S002 |
2012-05-01 |
135 Review Track For 30-day Notice |
| S001 |
2012-04-04 |
30-day Notice |
NIH GUDID Devices