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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 & SYNVISC-ONE (HYLAN G-F 20)
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS014
Date Received02/17/2009
Decision Date03/11/2009
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Removal of the cytotoxicity test (usp<87> biological reactivity test, in vitro) from the hylan b-10 gel in-process specification for the device.
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