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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-ONE
Classification Nameacid, hyaluronic, intraarticular
Generic Namehylan g-f 20
ApplicantGENZYME CORP.
PMA NumberP940015
Supplement NumberS012
Date Received06/19/2007
Decision Date02/26/2009
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 09M-0128
Notice Date 03/10/2009
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the synvisc-one. The device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have filed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e. G. , acetaminophen.
Approval Order Approval Order
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