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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNVISC (HYLAN G-F 20)
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi Genzyme Corp.
450 Water St.
Cambridge, MA 02141
PMA NumberP940015
Supplement NumberS003
Date Received04/07/1999
Decision Date12/20/1999
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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