|Trade Name||PHYSIO-STIM BONE GROWTH STIMULATOR|
|Classification Name||stimulator, bone growth, non-invasive|
|Generic Name||non-invasive bone growth stimulator|
||General & Plastic Surgery
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the definition of non-union in the labeling (i. E. , a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).