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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametargeted transurethral thermoablation for benign prostatic hyperplasia bph
PMA NumberP970008
Supplement NumberS029
Date Received05/10/2005
Decision Date03/23/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a radio frequency identification (rfid) system to prevent reuse of the disposable device components. The device, as modified, will be marketed under the trade name urologix targis system and is indicated for the delivery of microwave energy to the prostate for the treatment of bph in a single session. It is indicated for patients with prostatic lengths of 30 to 50 mm.