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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.
 
DeviceGEL-ONE
Classification Nameacid, hyaluronic, intraarticular
Generic Nameacid, hyaluronic, intraarticular
Applicant
SEIKAGAKU 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[ Registered Establishments with MOZ ]
Docket Number 11M-0198
Notice Date 03/31/2011
Advisory Committee Orthopedic
Clinical Trials NCT00449696
NCT00450112
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 
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