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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Applicant
BIOVENTUS LLC
4721 emperor blvd suite 100
durham, NC 27703
PMA NumberP900009
Supplement NumberS010
Date Received04/14/2000
Decision Date05/10/2000
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the wording of the indication statement.
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