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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
Predetermined Change Control Plan AuthorizedNo
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: S021 S020 S022  S028 S023 S026 S029 S033 S004 S012 S010 
S001 S002 S003 S006 S007 S039 S005 S024 S031 S027 S030 S032 
S034 S035 S008 S009 S017 S013 S011 S014 S018 S015 S019 S036 
S040 S038 S037 S045 S049 S047 S048 S041 S042 S043 S044 S046 
S051 S050 S052 S025 
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