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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.
 
DeviceEXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
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 NumberS028
Date Received07/20/2007
Decision Date08/16/2007
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacture of the exogen 4000+ device to a continuous flow manufacturing model and a change in the serial numbering scheme of the device.
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