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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceSYNVISC ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
450 Water St.
Cambridge, MA 02141
PMA NumberP940015
Date Received05/31/1994
Decision Date08/08/1997
Product Code MOZ 
Docket Number 98M-0217
Notice Date 04/07/1998
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S001 S002 S003 S006 S014 S011 S015 S018 S007 S013 S017 S040 
S028 S012  S023 S024 S004 S031 S029 S026 S027 S008 S009 
S033 S025 S032 S005 S030 S034 S035 S038 S039 S019 S036 S042 
S043 S044 S047 S046 S045 S048 S051 S049 S052 S010 S037 S041 
S050 S021 S020 S022 
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