Approval for the following changes to the manufacturing process: 1) replacement of wfi manufacturing equipment;2) addition of a sensor for preventing double capping;3) replacement of the multiplexer processor;4) addition of a syringe label sensor;5) replacement of the electronic balance;6) change of knockers used to push rubber pistons into glass syringes during the fillingmedia fill test (mft);7) addition of a second filtration tank in order to facilitate the manufacturing of plastic andglass syringe products on consecutive days; and 8) installation of a new storage room for raw material. The device, as modified, will be marketed under the trade name supartz® and is indicated forthe treatment of pain in osteoarthritis of the knee in patients who have failed to respondadequately to conservative nonpharmacologic therapy and simple analgesics, e. G. ,acetaminophen.
| Device | SUPARTZ |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | SEIKAGAKU CORP. |
| Date Received | 2008-07-21 |
| Decision Date | 2009-07-07 |
| PMA | P980044 |
| Supplement | S007 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| 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 | 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