Approval for a change of the trade name of your device from supartz to supartz fx. The device, as modified, will be marketed under the trade name supartz fx and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative, non-pharmacologic therapy and simple analgesics, e. G. , acetaminophen.
| Device | SUPARTZ FX |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | SEIKAGAKU CORP. |
| Date Received | 2015-04-07 |
| Decision Date | 2015-05-20 |
| PMA | P980044 |
| Supplement | S025 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980044 | | Original Filing |
| S059 |
2022-03-02 |
30-day Notice |
| S058 |
2021-10-26 |
30-day Notice |
| S057 |
2021-07-21 |
30-day Notice |
| S056 |
2021-04-28 |
30-day Notice |
| S055 |
2021-03-17 |
30-day Notice |
| S054 |
2020-10-13 |
30-day Notice |
| S053 |
2020-06-30 |
30-day Notice |
| S052 | | |
| S051 |
2018-12-20 |
30-day Notice |
| S050 |
2018-11-06 |
30-day Notice |
| S049 |
2018-10-16 |
30-day Notice |
| S048 |
2018-07-11 |
30-day Notice |
| S047 |
2018-05-18 |
Real-time Process |
| S046 |
2018-05-10 |
30-day Notice |
| S045 |
2018-04-25 |
30-day Notice |
| S044 | | |
| S043 |
2018-02-13 |
30-day Notice |
| S042 |
2018-01-11 |
30-day Notice |
| S041 |
2017-11-14 |
30-day Notice |
| S040 |
2017-06-30 |
30-day Notice |
| S039 |
2017-06-29 |
135 Review Track For 30-day Notice |
| S038 |
2017-02-28 |
30-day Notice |
| S037 |
2017-02-24 |
30-day Notice |
| S036 |
2016-12-23 |
30-day Notice |
| S035 |
2016-08-19 |
30-day Notice |
| S034 |
2016-08-16 |
30-day Notice |
| S033 | | |
| S032 |
2016-04-19 |
30-day Notice |
| S031 |
2016-02-23 |
30-day Notice |
| S030 |
2015-12-09 |
30-day Notice |
| S029 |
2015-11-10 |
30-day Notice |
| S028 |
2015-10-30 |
Normal 180 Day Track |
| S027 |
2015-07-08 |
Panel Track |
| S026 |
2015-06-17 |
30-day Notice |
| S025 |
2015-04-07 |
Normal 180 Day Track No User Fee |
| S024 |
2014-11-24 |
Normal 180 Day Track |
| S023 |
2014-11-21 |
30-day Notice |
| S022 |
2014-11-20 |
30-day Notice |
| S021 |
2014-11-19 |
30-day Notice |
| S020 |
2014-11-18 |
30-day Notice |
| S019 |
2014-08-29 |
30-day Notice |
| S018 |
2014-05-01 |
30-day Notice |
| S017 |
2013-12-18 |
30-day Notice |
| S016 |
2013-06-28 |
30-day Notice |
| S015 |
2013-06-12 |
30-day Notice |
| S014 |
2012-08-20 |
30-day Notice |
| S013 |
2012-04-04 |
30-day Notice |
| S012 |
2010-03-11 |
135 Review Track For 30-day Notice |
| S011 | | |
| S010 |
2009-08-27 |
30-day Notice |
| S009 |
2009-02-26 |
Normal 180 Day Track No User Fee |
| S008 |
2008-07-30 |
30-day Notice |
| S007 |
2008-07-21 |
135 Review Track For 30-day Notice |
| S006 |
2007-01-30 |
Special (immediate Track) |
| S005 |
2006-08-01 |
135 Review Track For 30-day Notice |
| S004 |
2006-07-26 |
30-day Notice |
| S003 |
2004-09-14 |
Normal 180 Day Track |
| S002 |
2004-06-07 |
Normal 180 Day Track |
| S001 |
2004-04-29 |
30-day Notice |
NIH GUDID Devices