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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.
 
Trade NameUROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametargeted transurethral thermoablation for benign prostatic hyperplasia bph
ApplicantUROLOGIX, INC.
PMA NumberP970008
Supplement NumberS026
Date Received02/25/2005
Decision Date06/16/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product 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.
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