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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.
 
DeviceSINOVIAL (SODIUM HYALURONATE 0.8%)
Generic NameAcid, hyaluronic, intraarticular
ApplicantIbsa Institut Biochimique SA
Via Al Ponte 13, Ch-6903
Lugano Ticino 6903
PMA NumberP110005
Date Received02/10/2011
Decision Date05/09/2014
Product Code MOZ 
Docket Number 14M-0691
Notice Date 05/29/2014
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR GEL-SYN. 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 NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS (E.G. ACETAMINOPHEN).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S005 S006 S007 S013 S009 S011 S003 S015 S004 
S008 S012 S014 
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