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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 2000+ 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 NumberS023
Date Received05/15/2006
Decision Date06/30/2006
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the incorporation of a dri-shield 2000 moisture barrier bag (electrostatic discharge [esd] bag) as part of the device packaging.
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