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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORP.
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: sterilization
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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