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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM
Generic NameStimulator, ultrasound and muscle, for use other than applying therapeutic deep
ApplicantBIOVENTUS LLC
4721 EMPEROR BLVD SUITE 100
DURHAM, NC 27703
PMA NumberP900009
Supplement NumberS016
Date Received12/20/2002
Decision Date02/21/2003
Product Code LPQ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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