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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 AVENUE
BEDFORD, MA 01730
PMA NumberP030019
Supplement NumberS008
Date Received01/03/2006
Decision Date01/30/2006
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE BULK CONCENTRATE PROCESS TO NO LONGER INCLUDE THE CHLOROFORM TREATMENT STEP.
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