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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.
 
DeviceSUPARTZ
Generic NameAcid, hyaluronic, intraarticular
ApplicantSeikagaku Corp.
6-1, Marunouchi 1-Chome,
Chiyoda-Ku
Tokyo 100-0005
PMA NumberP980044
Supplement NumberS007
Date Received07/21/2008
Decision Date07/07/2009
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 FOLLOWING CHANGES TO THE MANUFACTURING PROCESS: 1) REPLACEMENT OF WFI MANUFACTURING EQUIPMENT;2) ADDITION OF A SENSOR FOR PREVENTING DOUBLE CAPPING;3) REPLACEMENT OF THE MULTIPLEXER PROCESSOR;4) ADDITION OF A SYRINGE LABEL SENSOR;5) REPLACEMENT OF THE ELECTRONIC BALANCE;6) CHANGE OF KNOCKERS USED TO PUSH RUBBER PISTONS INTO GLASS SYRINGES DURING THE FILLINGMEDIA FILL TEST (MFT);7) ADDITION OF A SECOND FILTRATION TANK IN ORDER TO FACILITATE THE MANUFACTURING OF PLASTIC ANDGLASS SYRINGE PRODUCTS ON CONSECUTIVE DAYS; AND 8) INSTALLATION OF A NEW STORAGE ROOM FOR RAW MATERIAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUPARTZ® AND IS INDICATED FORTHE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPONDADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G.,ACETAMINOPHEN.
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