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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.
 
DeviceORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
Generic NameAcid, hyaluronic, intraarticular
ApplicantAnika Therapeutics, Inc.
32 Wiggins Ave.
Beford, MA 01730
PMA NumberP030019
Supplement NumberS013
Date Received07/24/2006
Decision Date03/15/2007
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE FILTER USED IN THE STERILE FILTRATION OF SODIUM HYALURONATE SOLUTION.
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