Change to the final device back-up storage facility for supartz fx and visco-3.
Device | SUPARTZ FX and VISCO-3 |
Classification Name | Acid, Hyaluronic, Intraarticular |
Generic Name | Acid, Hyaluronic, Intraarticular |
Applicant | SEIKAGAKU CORP. |
Date Received | 2017-06-30 |
Decision Date | 2017-07-28 |
PMA | P980044 |
Supplement | S040 |
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 |
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