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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.
 
DeviceEXOGEN® Ultrasound Bone Healing System
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantBioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703
PMA NumberP900009
Supplement NumberS049
Date Received07/20/2023
Decision Date12/21/2023
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional manufacturing site (Bioventus LLC, Cordova, Tennessee, FEI # 302669735) for the EXOGEN Ultrasound Bone Healing System.
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