Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

New Search Back to Search Results
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 and Synvisc-One
Generic NameAcid, hyaluronic, intraarticular
ApplicantSanofi Genzyme Corp.
450 Water St.
Cambridge, MA 02141
PMA NumberP940015
Supplement NumberS048
Date Received06/01/2021
Decision Date06/29/2021
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Incorporation of a magnetic filter into the manufacturing process for Synvisc and Synvisc-One.
  We welcome your comments and feedback about Devices@FDA.
-
-