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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: S019 S017  S018 S013 S028 S029 S009 S004 S005 S003 S032 
S036 S026 S027 S014 S030 S020 S021 S022 S023 S024 S015 S016 
S025 S001 S002 S007 S008 S010 S012 S006 S031 S039 S040 S033 
S037 S038 S034 S035 S041 S048 S046 S047 S043 S053 S049 S057 
S055 S056 S059 S045 S042 S054 S051 S050 S058 
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