|Trade Name||EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND 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||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a new contract vendor for the supply of components/ materials used in the manufacturing process.