|Trade Name||EXOGEN 2000+ LOW INTENSITY FRACTURE 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||special (immediate track)|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a new circuit board inspection step for the exogen 2000+ device.