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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 3000* LOW INTENSITY FRACTURE 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 NumberS016
Date Received12/20/2002
Decision Date02/21/2003
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
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 changes to the exogen 3000* labeling in order that it more closely resemble the approved labeling for the exogen 2000+*.
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