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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSUPARTZ FX
Generic NameAcid, hyaluronic, intraarticular
ApplicantSEIKAGAKU CORP.
6-1, MARUNOUCHI 1-CHOME,
CHIYODA-KU
TOKYO 100-0-0005
PMA NumberP980044
Date Received12/01/1998
Decision Date01/24/2001
Product Code MOZ 
Docket Number 01M-0342
Notice Date 08/13/2001
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S045 S046 S047 S048 S049 
S050 S051 S053 S054 S055 S056 S057 S058 S059 
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