|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 BPH THERMOTHERAPY SYSTEM|
|Classification Name||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new manufacturing site located at manufacturing and research, inc. , tucson, arizona. The rx-200 applicator will be manufactured at this facility.