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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 NameHYALGAN
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantFIDIA FARMACEUTICI
PMA NumberP950027
Supplement NumberS011
Date Received02/27/2008
Decision Date05/23/2008
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the section of adverse events with a qualitative description of the types and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e. G. , acetaminophen.
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