|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||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a longer version of the cooled thermocath microwave delivery catheter. The longer antenna is 37 mm compared to the 28 mm antenna in the currently approved cooled thermocath catheter. The device, as modified, will be marketed under the trade name cooled thermocath 4. 5+ and is indicated for men with prostatic urethral lengths of 4. 5 cm or greater.