Approval for revisions of the instructions for use (ifu) and the patient information (pi) for supartz as follows:1) revision in the ifu and pi of the statement, ¿the safety and effectiveness of repeat treatment cycles of supartz have not been established. ¿ to ¿the effectiveness of repeat treatment cycles of supartz has not been established. ¿; and 2) insertion in the ifu and pi of the statements, ¿adverse experience data from the literature contain no evidence of increased safety risk relating to retreatment with supartz. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. ¿
| Device | SUPARTZ |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | SEIKAGAKU CORP. |
| Date Received | 2014-11-24 |
| Decision Date | 2015-03-31 |
| PMA | P980044 |
| Supplement | S024 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day 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 |
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