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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.
 
DeviceSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantBioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703
PMA NumberP900009
Supplement NumberS050
Date Received02/06/2026
Decision Date03/06/2026
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in the manufacturing facility associated with the transducer cable assembly for the EXOGEN Ultrasound Bone Healing System.
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