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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.
50 binney street
cambridge, MA 02142
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: S038 S039  S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S018 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 
S035 S036 S037 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 
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