|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 Name||EXOGEN 3000 SONIC ACCELERATED 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||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in labeling for the exogen 3000(r), to incorporate both the fresh fracture and nonunion information into one set of physician's instructions for use, patient's instructions for use, and product insert bulletin; to make manual size and formatting changes, and to add nonunion background information.