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 | Suparts FX & Visco-3 |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP980044 Supplement NumberS059 Date Received03/02/2022 Decision Date03/31/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-03-31 |
| PMA | P980044 |
| Supplement | S059 |
| 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 NumberP980044 Supplement NumberS059 Date Received03/02/2022 Decision Date03/31/2022 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 a Change To The Near Infrared (NIR) Testing Conditions |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05060548950057 | P980044 | 000 |
| 05060459970120 | P980044 | 000 |
| 10389130444418 | P980044 | 000 |
| M717715644440 | P980044 | 019 |
| 04987541301314 | P980044 | 027 |