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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 NumberS002
Date Received10/16/1998
Decision Date02/19/1999
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for a manufacturing site located at Biomatrix, Inc., 1125 Pleasantview Terrace, Radgefield, NJ.
  We welcome your comments and feedback about Devices@FDA.
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