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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
PMA NumberP980044
Supplement NumberS024
Date Received11/26/2014
Decision Date03/31/2015
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Clinical Trials NCT00479687
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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. ¿.