Modifications to the sterilization process of a component used to manufacture synvisc and synvisc-one.
| Device | SYNVISC ONE |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Sanofi GENZYME CORP. |
| Date Received | 2017-04-17 |
| Decision Date | 2017-05-11 |
| PMA | P940015 |
| Supplement | S040 |
| 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 | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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