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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 NumberS006
Date Received07/02/1998
Decision Date02/22/2000
Product Code LPQ 
Docket Number 00M-0810
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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