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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 NumberS006
Date Received01/30/2007
Decision Date03/07/2007
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding both possible adverse reactions reported worldwide to the instruction for use, and the possible side effects collected from worldwide post-market experience to the patient information brochure.
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