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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+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
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 NumberS024
Date Received10/02/2006
Decision Date11/01/2006
Reclassified Date05/18/2026
Product Code LPQ 
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  
ADDITION OF SAFT AMERICA, INC., VALDESE, NORTH CAROLINA, AS A NEW CONTRACT VENDOR FOR THE MANUFACTURING OF BATTERY PACKS FOR THE REFERENCED DEVICE.
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