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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
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORPORATION
PMA NumberP940015
Supplement NumberS019
Date Received06/09/2010
Decision Date09/15/2010
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
P940015/s019 9/15/10 135-day synvisc/synvisc-one and prevelle silk genzyme biosurgery cambridge, ma 02142 approval for a manufacturing change involving installation of the waters empower 2 chromatography data system.
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