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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 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 & SYNVISC-ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi GENZYME CORP.
50 Binney Street
Cambridge, MA 02142
PMA NumberP940015
Supplement NumberS019
Date Received06/09/2010
Decision Date09/15/2010
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
P940015/S0199/15/10135-DAY SYNVISC/SYNVISC-ONE AND PREVELLE SILK GENZYME BIOSURGERYCAMBRIDGE, MA02142 APPROVAL FOR A MANUFACTURING CHANGE INVOLVING INSTALLATION OF THE WATERS EMPOWER 2 CHROMATOGRAPHY DATA SYSTEM.
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