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. |
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Device | SUPARTZ |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | SEIKAGAKU CORP. 6-1, MARUNOUCHI 1-CHOME, CHIYODA-KU TOKYO 100-0-0005 |
PMA Number | P980044 |
Supplement Number | S007 |
Date Received | 07/21/2008 |
Decision Date | 07/07/2009 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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