|Trade Name||EXOGEN 2000+ AND EXOGEN 3000|
|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 two design and component changes: 1) changes to exogen 2000+ printed circuit board to implement corrective action for field failure and returns. This corrective action involves two design changes: i) replace 2 diodes on te printed circuit board with light emitting diodes. Ii) add a 1000 pf capacitor to reduce electrical noise. 2) replace both exogen 2000+ and exogen 3000 transducer cables with a more cost effective model.