Approval for synvisc(r) hylan g-f 20. This device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e. G. , acetaminophen.
| Device | SYNVISC ONE |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Sanofi GENZYME CORP. |
| Date Received | 1994-05-31 |
| Decision Date | 1997-08-08 |
| Notice Date | 1998-04-07 |
| PMA | P940015 |
| Supplement | S |
| Product Code | MOZ |
| Docket Number | 98M-0217 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Sanofi GENZYME CORP. 50 Binney Street cambridge, MA 02142 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940015 | | Original Filing |
| S051 |
2022-12-16 |
30-day Notice |
| S050 |
2022-09-30 |
Special (immediate Track) |
| S049 |
2021-08-11 |
30-day Notice |
| S048 |
2021-06-01 |
30-day Notice |
| S047 | | |
| S046 |
2020-06-25 |
30-day Notice |
| S045 |
2019-12-05 |
30-day Notice |
| S044 |
2018-12-17 |
30-day Notice |
| S043 |
2018-12-13 |
30-day Notice |
| S042 |
2018-11-30 |
30-day Notice |
| S041 |
2018-05-24 |
135 Review Track For 30-day Notice |
| S040 |
2017-04-17 |
30-day Notice |
| S039 |
2017-02-28 |
30-day Notice |
| S038 |
2016-12-12 |
30-day Notice |
| S037 |
2016-09-29 |
30-day Notice |
| S036 |
2016-03-17 |
30-day Notice |
| S035 |
2015-04-28 |
30-day Notice |
| S034 |
2015-04-24 |
Real-time Process |
| S033 |
2014-07-09 |
Special (immediate Track) |
| S032 |
2014-04-15 |
30-day Notice |
| S031 |
2014-01-14 |
30-day Notice |
| S030 |
2013-11-08 |
30-day Notice |
| S029 |
2013-09-25 |
135 Review Track For 30-day Notice |
| S028 |
2013-08-26 |
135 Review Track For 30-day Notice |
| S027 |
2013-05-31 |
30-day Notice |
| S026 |
2012-05-07 |
30-day Notice |
| S025 |
2011-12-20 |
135 Review Track For 30-day Notice |
| S024 |
2011-12-09 |
30-day Notice |
| S023 |
2011-09-02 |
30-day Notice |
| S022 |
2011-08-05 |
30-day Notice |
| S021 |
2011-06-07 |
30-day Notice |
| S020 |
2011-02-16 |
30-day Notice |
| S019 |
2010-06-09 |
135 Review Track For 30-day Notice |
| S018 |
2010-04-22 |
135 Review Track For 30-day Notice |
| S017 |
2010-01-29 |
30-day Notice |
| S016 | | |
| S015 |
2009-04-16 |
Real-time Process |
| S014 |
2009-02-17 |
30-day Notice |
| S013 |
2008-09-25 |
135 Review Track For 30-day Notice |
| S012 |
2007-06-19 |
Panel Track |
| S011 |
2007-02-20 |
Normal 180 Day Track |
| S010 |
2003-08-15 |
Special (immediate Track) |
| S009 |
2003-02-14 |
Special (immediate Track) |
| S008 |
2003-01-15 |
Real-time Process |
| S007 |
2002-03-29 |
Special (immediate Track) |
| S006 |
2002-03-19 |
Real-time Process |
| S005 |
2000-03-31 |
Real-time Process |
| S004 |
1999-05-03 |
Special (immediate Track) |
| S003 |
1999-04-07 |
Normal 180 Day Track |
| S002 |
1998-10-16 |
Normal 180 Day Track |
| S001 |
1998-09-29 |
Special (immediate Track) |
NIH GUDID Devices