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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.
 
DeviceSUPARTZ
Generic NameAcid, hyaluronic, intraarticular
ApplicantSeikagaku Corp.
6-1, Marunouchi 1-Chome,
Chiyoda-Ku
Tokyo 100-0005
PMA NumberP980044
Supplement NumberS024
Date Received11/24/2014
Decision Date03/31/2015
Product Code MOZ 
Advisory Committee Orthopedic
Clinical TrialsNCT00479687
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 OF THE INSTRUCTIONS FOR USE (IFU) AND THE PATIENT INFORMATION (PI) FOR SUPARTZ AS FOLLOWS:1) REVISION IN THE IFU AND PI OF THE STATEMENT, ¿THE SAFETY AND EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF SUPARTZ HAVE NOT BEEN ESTABLISHED.¿ TO ¿THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF SUPARTZ HAS NOT BEEN ESTABLISHED.¿; AND 2) INSERTION IN THE IFU AND PI OF THE STATEMENTS, ¿ADVERSE EXPERIENCE DATA FROM THE LITERATURE CONTAIN NO EVIDENCE OF INCREASED SAFETY RISK RELATING TO RETREATMENT WITH SUPARTZ. THE FREQUENCY AND SEVERITY OF ADVERSE EVENTS OCCURRING DURING REPEAT TREATMENT CYCLES DID NOT INCREASE OVER THAT REPORTED FOR A SINGLE TREATMENT CYCLE.¿
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