This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Synvisc and Synvisc-One |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Sanofi GENZYME CORP.50 Binney Streetcambridge, MA 02142 PMA NumberP940015 Supplement NumberS050 Date Received09/30/2022 Decision Date11/04/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-11-04 |
| PMA | P940015 |
| Supplement | S050 |
| Product Code | MOZ |
| 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 PMA NumberP940015 Supplement NumberS050 Date Received09/30/2022 Decision Date11/04/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Revisions Of The Synvisc® And Synvisc-One® Physician Labeling To Include A Warning Statement Regarding Skin Necrosis And The Synvisc® And Synvisc-One® Patient Labeling To Include An Advisory For The Patient To Inform His/her Doctor In The Event Of Development Of A Skin Disorder After Treatment. |
| 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) |
| Device ID | PMA | Supp |
|---|---|---|
| 00358468019103 | P940015 | 000 |
| 05060548950019 | P940015 | 000 |
| 5060459970014 | P940015 | 000 |
| 08437027710056 | P940015 | 000 |
| 08437027710049 | P940015 | 000 |
| 20358468019114 | P940015 | 012 |
| 05060459970021 | P940015 | 034 |