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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.
 
Trade NameSONIC ACCELERATED FRACTURE HEALING SYSTEM
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namelow-intensity pulsed ultrasonic device for the treatment on nonunion
ApplicantEXOGEN
PMA NumberP900009
Supplement NumberS007
Date Received07/07/1999
Decision Date08/25/1999
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a name change from safhs 2000(r) to exogen 2000(r). The device is indicated for the acceleration of the time to a healed fracture for fresh*, closed, posteriorly displaced distal radius (colles') fractures, and fresh*, closed or grade i open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. *all fractures in both clinical studies were treated with safhs(r) therapy within seven days for fracture.
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