|Trade Name||SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)|
|Classification Name||stimulator, ultrasound and muscle, for use other than applying therapeutic deep|
|Generic Name||stimulator, ultrasound and muscle, for use other than applying therapeutic deep|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the wording of the indication statement.