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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 (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
GENZYME CORP.
55 cambridge parkway
4th floor
cambridge, MA 02142
PMA NumberP940015
Supplement NumberS018
Date Received04/22/2010
Decision Date11/24/2010
Product Code
MOZ[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL FOR THE INTRODUCTION OF FEDEGARI AUTOCLAVE AS AN ADDITIONAL AUTOCLAVE IN THE MANUFACTURING PROCESS.
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