|Trade Name||UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH|
|Classification Name||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Generic Name||targeted transurethral thermoablation for benign prostatic hyperplasia bph|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes to the device: 1) the change of the insertion tip and adhesive of the cooled thermocath microwave delivery system (ctc mds) to increase to the flexibility of the catheter; 2) the change of the insertion tip and adhesive of the targis microwave delivery system to the same catheter type as the ctc mds; and 3) the addition of texin 950 uv stabilized tubing for the shaft of the ctc catheter.