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, Synvisc-One |
Generic Name | Acid, Hyaluronic, Intraarticular |
Applicant | Sanofi GENZYME CORP.50 Binney Streetcambridge, MA 02142 PMA NumberP940015 Supplement NumberS051 Date Received12/16/2022 Decision Date01/13/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-12-16 |
Decision Date | 2023-01-13 |
PMA | P940015 |
Supplement | S051 |
Product Code | MOZ |
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 PMA NumberP940015 Supplement NumberS051 Date Received12/16/2022 Decision Date01/13/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement replacement Of The Water Distribution System (piping) Used To Supply Water In The Manufacture Of Synvisc And Synvisc-One |
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 |
20358468019114 | P940015 | 012 |
05060459970021 | P940015 | 034 |