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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSYNVISC ONE
Classification Nameacid, hyaluronic, intraarticular
ApplicantGENZYME CORP.
PMA NumberP940015
Date Received05/31/1994
Decision Date08/08/1997
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 98M-0217
Notice Date 04/07/1998
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for synvisc(r) hylan g-f 20. This device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e. G. , acetaminophen.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 
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