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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 3000 SONIC ACCELERATED FRACTURE 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 NumberS012
Date Received10/12/2000
Decision Date02/21/2001
Reclassified Date05/18/2026
Product Code LPQ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN LABELING FOR THE EXOGEN 3000(R), TO INCORPORATE BOTH THE FRESH FRACTURE AND NONUNION INFORMATION INTO ONE SET OF PHYSICIAN'S INSTRUCTIONS FOR USE, PATIENT'S INSTRUCTIONS FOR USE, AND PRODUCT INSERT BULLETIN; TO MAKE MANUAL SIZE AND FORMATTING CHANGES, AND TO ADD NONUNION BACKGROUND INFORMATION.
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