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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.
 
Trade NameEXOGEN 4000+ 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
ApplicantBIOVENTUS LLC
PMA NumberP900009
Supplement NumberS030
Date Received12/23/2008
Decision Date03/13/2009
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate supplier for the manufacturing of the printed circuit board assembly (pcba).
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