|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||TMX-2000 (TM) BPH THERMOTHERAPY SYSTEM|
|Classification Name||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for design changes to the rx-200 applicator of the tmx-2000 bph thermotherapy system.