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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 NameSUPARTZ DISPO
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantSEIKAGAKU CORP.
PMA NumberP980044
Date Received12/01/1998
Decision Date01/24/2001
Product Code
MOZ[ Registered Establishments with MOZ ]
Docket Number 01M-0342
Notice Date 08/13/2001
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 supartz(tm) dispo. The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e. G. , acetaminophen.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S012 S013 S014 S015 S016 S017 S018 
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