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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGEL-ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantSeikagaku Corp.
6-1, Marunouchi 1-Chome,
Chiyoda-Ku
Tokyo 100-0005
PMA NumberP080020
Supplement NumberS014
Date Received05/05/2015
Decision Date08/03/2015
Product Code MOZ 
Advisory Committee Orthopedic
Clinical TrialsNCT00449696
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE PACKAGE INSERT AND THE PATIENT INFORMATION FOR GEL-ONE® AS FOLLOWS: 1) REVISION OF THE STATEMENT, THE SAFETY AND EFFECTIVENESS OF A REPEAT TREATMENT CYCLE OF GEL-ONE® HAVE NOT BEEN ESTABLISHED. TO THE STATEMENT, THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF GEL-ONE® HAS NOT BEEN ESTABLISHED; AND 2) CITATION OF CLINICAL STUDY DATA FOR RETREATMENT WITH GEL-ONE® IN SUPPORT OF THE REVISION OF THIS STATEMENT AS DESCRIBED ABOVE.
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