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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.
 
DeviceGEL-ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantSEIKAGAKU CORP.
6-1, MARUNOUCHI 1-CHOME,
CHIYODA-KU
TOKYO 100-0-0005
PMA NumberP080020
Date Received07/31/2008
Decision Date03/22/2011
Product Code MOZ 
Docket Number 11M-0198
Notice Date 03/31/2011
Advisory Committee Orthopedic
Clinical TrialsNCT00449696
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GEL-ONE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO NON-PHARMACOLOGIC THERAPY, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) OR ANALGESICS, E.G., ACETAMINOPHEN.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S009 S010 S011 S012 S001 S004 S007 S014 S024 S006 S013 
S015 S016 S017 S003 S008 S002 S018 S005 S019 S020 S026 S021 
S025 S022 S023 S030 S027 S035 S031 S042 S051 S045 S046 S029 
S028 S038 S032 S033 S039 S040 S036 S037 S049 S048 S043 S047 
S044 S052 
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