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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 4000+ BONE HEALING SYSTEM
Generic NameStimulator, ultrasound and muscle, for use other than applying therapeutic deep
Regulation Number890.5870
ApplicantBioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703
PMA NumberP900009
Supplement NumberS030
Date Received12/23/2008
Decision Date03/13/2009
Reclassified Date05/18/2026
Product Code LPQ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE MANUFACTURING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).
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