Approval for changes to the patient package insert for synvisc that are intended to strengthen the information for patients by increasing the type size, decreasing the reading level, more fully describing the u. S. Clinical trial, describing the signs of an allergic reaction, and by making other revisions to the insert.
| Device | SYNVISC HYLAN G-F 20 |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Sanofi GENZYME CORP. |
| Date Received | 2003-08-15 |
| Decision Date | 2003-09-12 |
| PMA | P940015 |
| Supplement | S010 |
| Product Code | MOZ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Sanofi GENZYME CORP. 50 Binney Street cambridge, MA 02142 |
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