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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.
 
DeviceGENVISC 850
Generic NameAcid, hyaluronic, intraarticular
ApplicantORTHOGENRX,INC
2005 South Easton Road
Suite 207
Doylestown, PA 18901
PMA NumberP140005
Date Received04/16/2014
Decision Date09/02/2015
Product Code MOZ 
Docket Number 15M-3258
Notice Date 10/15/2015
Advisory Committee Orthopedic
Clinical TrialsNCT00669032
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR GENVISC 850®. THIS DEVICE IS INDICATED FOR OR 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:  S004 S005 
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