|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||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to remove the contraindication for patients with prostatic or bladder cancer, and add the precaution stating that the safety and effectiveness of the thermatrx tmx-2000 has not been established in patients with clinical or histological evidence of prostate or bladder cancer.