|Trade Name||PROSTALUND CORETHERM SYSTEM|
|Classification Name||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Generic Name||transurethral microwave/thermal therapy system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. The device, as modified, will be marketed under the trade name coretherm accessories for small prostates and is indicated for use together with prostalund coretherm /se in patients with glands size 20-50g and with a prostate length ¿25 mm.