SYNVISC ONE

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P940015

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for synvisc(r) hylan g-f 20. This device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e. G. , acetaminophen.

DeviceSYNVISC ONE
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantSanofi GENZYME CORP.
Date Received1994-05-31
Decision Date1997-08-08
Notice Date1998-04-07
PMAP940015
SupplementS
Product CodeMOZ
Docket Number98M-0217
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Sanofi GENZYME CORP. 50 Binney Street cambridge, MA 02142
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P940015Original 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

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

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