Change in final packaging equipment.
Device | SYNVISC |
Classification Name | Acid, Hyaluronic, Intraarticular |
Generic Name | Acid, Hyaluronic, Intraarticular |
Applicant | Sanofi GENZYME CORP. |
Date Received | 2014-01-14 |
Decision Date | 2014-02-12 |
PMA | P940015 |
Supplement | S031 |
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