Synvisc/Synvisc-One

FDA Premarket Approval P940015 S045

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.

Pre-market Approval Supplement Details

Modifications to the washing process of a component used to manufacture synvisc and synvisc-one

DeviceSynvisc/Synvisc-One
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSanofi GENZYME CORP.
Date Received2019-12-05
Decision Date2020-01-16
PMAP940015
SupplementS045
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Sanofi GENZYME CORP. 50 Binney Street cambridge, MA 02142

Supplemental Filings

Supplement NumberDateSupplement Type
P940015Original Filing
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

Device IDPMASupp
00358468019103 P940015 000
05060548950019 P940015 000
5060459970014 P940015 000
20358468019114 P940015 012
20358468019114 P940015 012
05060459970021 P940015 034

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.