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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.
 
Trade NameORTHOVISC SODIUM HYALURONATE
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP030019
Supplement NumberS006
Date Received07/01/2004
Decision Date12/28/2004
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the labeling to include safety information concerning a repeat course of treatment of orthovisc.
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