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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSUPARTZ
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantSEIKAGAKU CORP.
PMA NumberP980044
Supplement NumberS003
Date Received09/14/2004
Decision Date01/20/2006
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes including modifying the directions for use section to include a statement regarding the use of a course of 3 injections, and adding information about adverse events.
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