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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 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
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 NumberS025
Date Received02/22/2007
Decision Date06/11/2007
Product Code LPQ 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL SUPPLIER OF THE EXTERNAL PLASTIC HOUSING FOR THE MAIN OPERATING UNIT. THIS INCLUDES THE TOP HOUSING, THE BOTTOM HOUSING, THE PUSH BUTTON AND THE LENS.
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