|Trade Name||EXOGEN 4000+BONE HEALING SYSTEM|
|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|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes in internal device circuitry as mitigation against known device failure mechanisms which do not impact upon ultrasound output or signal parameters.