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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.
 
DeviceDUROLANE
Generic NameAcid, hyaluronic, intraarticular
ApplicantBioventus LLC
4721 Emperor Blvd, Suite 100
Durham, NC 27703
PMA NumberP170007
Supplement NumberS006
Date Received04/29/2020
Decision Date10/08/2020
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the removal of testing of heavy metals in raw materials for DUROLANE as per USP<231> and replacing it by a risk analysis on the final product based on ICH Q3D Guideline for Elemental Impurities.
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