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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEUFLEXXA 1% SODIUM HYALURONATE
Generic NameAcid, hyaluronic, intraarticular
ApplicantFerring Pharmaceuticals, Inc.
100 Interpace Pkwy.
Parsippany, NJ 07054
PMA NumberP010029
Supplement NumberS007
Date Received05/02/2008
Decision Date07/01/2009
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE STERILE SODIUM HYALURONATE (NAHA) TO BE STORED IN STERILE, DISPOSABLE POLYETHYLENE BAGS FOR UP TO 48 HOURS PRIOR TO FILLING THE SYRINGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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