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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
PMA NumberP980044
Supplement NumberS002
Date Received06/07/2004
Decision Date09/10/2004
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of a plastic syring barrel with luer lock, in addition to the existing glass syringe barrel product.
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