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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.
 
DeviceSONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Applicant
BIOVENTUS LLC
4721 emperor blvd suite 100
durham, NC 27703
PMA NumberP900009
Supplement NumberS006
Date Received07/02/1998
Decision Date02/22/2000
Product Code
LPQ[ Registered Establishments with 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 Product No
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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