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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 NameSYNVISC (HYLAN G-F 20)
Classification Nameacid, hyaluronic, intraarticular
ApplicantBIOMATRIX, INC.
PMA NumberP940015
Supplement NumberS003
Date Received04/07/1999
Decision Date12/20/1999
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change in the physician package insert to reflect information in the patient package insert regarding the time of maximum treatment effect.
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