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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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51 supplements returned for P940015

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
synvisc hylan g-f 20

supplement #: S010
Sanofi Genzyme Corp. Sep 12, 2003 labeling change - indications/instructions/shelf life/tradename  
synvisc hylan g-f 20

supplement #: S011
Sanofi Genzyme Corp. Jun 09, 2008 labeling change - indications/instructions/shelf life/tradename  
synvisc-one

supplement #: S012
Sanofi Genzyme Corp. Feb 26, 2009 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
synvisc

supplement #: S013
Sanofi Genzyme Corp. Apr 10, 2009 process change - manufacturer/sterilizer/packager/supplier  
synvisc & synvisc-one (hylan g-f 20)

supplement #: S014
Sanofi Genzyme Corp. Mar 11, 2009 process change - manufacturer/sterilizer/packager/supplier  
synvisc

supplement #: S015
Sanofi Genzyme Corp. Aug 20, 2009 labeling change - indications/instructions/shelf life/tradename  
synvisc-one (hylan g-f 20)

supplement #: S017
Sanofi Genzyme Corp. Mar 12, 2010 process change - manufacturer/sterilizer/packager/supplier  
synvisc (hylan g-f 20) and synvisc-one (hylan g-f 20)

supplement #: S018
Sanofi Genzyme Corp. Nov 24, 2010 process change - manufacturer/sterilizer/packager/supplier  
synvisc & synvisc-one

supplement #: S019
Sanofi Genzyme Corp. Sep 15, 2010 process change - manufacturer/sterilizer/packager/supplier  
synvisc & synvisc-one

supplement #: S020
Sanofi Genzyme Corp. Mar 18, 2011 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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