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 | Gel-One |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS049 Date Received09/20/2022 Decision Date10/19/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-20 |
| Decision Date | 2022-10-19 |
| PMA | P080020 |
| Supplement | S049 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SEIKAGAKU CORP. 6-1, Marunouchi 1-chome, chiyoda-ku tokyo 100-0-0005 PMA NumberP080020 Supplement NumberS049 Date Received09/20/2022 Decision Date10/19/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement elimination Of Existing Distiller For Water For Injection (WFI) |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00087541300912 | P080020 | 012 |
| 04987541300911 | P080020 | 012 |