|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.|
|Classification Name||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Generic Name||transurethral microwave therotherapy (tumt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the prostatron software program to include the 30-minute tumt treatment protocol.