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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 NumberS046
Date Received03/16/2021
Decision Date04/14/2021
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  
Use an additional supplier for the ultrasound gel provided with the EXOGEN Ultrasound Bone Healing System.
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