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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(R)
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, sodium hyaluronic
PMA NumberP950027
Supplement NumberS001
Date Received06/24/1997
Decision Date07/08/1997
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason location change: distributor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the u. S. Distributor, sanofi pharmaceuticals, inc. , new york, new york. Additionally, we have reviewed the editorial changes you propose for the labeling for your product and have determined that they are appropriate.