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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 NumberS002
Date Received02/06/2019
Decision Date03/13/2019
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  
Modification to a cleanroom utilized in the manufacture of DUROLANE.
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