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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 NameORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP030019
Date Received05/30/2003
Decision Date02/04/2004
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 06M-0339
Notice Date 08/24/2006
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 the orthovisc high molecular weight hyaluronan. The device is indicated fo the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).
Approval Order Approval Order
Supplements: S001 S003 S004 S005 S006 S008 S009 S010 S012 
S013 S014 S015 S017 
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