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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.
 
DeviceHYMOVIS
Generic NameAcid, hyaluronic, intraarticular
ApplicantFIDIA FARMACEUTICI
PONTE DELLA FABBRICA 3/A
ABANO TERME 35031
PMA NumberP150010
Date Received02/25/2015
Decision Date08/28/2015
Product Code MOZ 
Docket Number 15M-3256
Notice Date 10/14/2015
Advisory Committee Orthopedic
Clinical TrialsNCT01372475
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR HYMOVIS. 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 TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 
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