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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.
 
DeviceSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000
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 NumberS003
Date Received01/02/1996
Decision Date03/27/1997
Product Code LPQ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000(TM).
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