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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 BONE HEALING SYSTEM
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 NumberS031
Date Received06/09/2009
Decision Date10/02/2009
Product Code
LPQ
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located in memphis, tennessee.
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