|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||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification of the prostatron labeling regarding the treatment of patients 1) with implanted active devices (including pacemakers and defibrillators), 2) in urinary retention, and 3) with median prostatic lobes.