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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 HIGH MOLECULAR WEIGHT HYALURONAN
Classification Nameacid, hyaluronic, intraarticular
Generic Namesodium hyaluronate
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP030019
Supplement NumberS012
Date Received08/17/2006
Decision Date11/08/2006
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for elimination of the second sterilization step from the final packaging process, and an update to the package labeling to reflect this change.
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