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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
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametargeted transurethral thermoablation for benign prostatic hyperplasia bph
ApplicantUROLOGIX, INC.
PMA NumberP970008
Supplement NumberS060
Date Received12/20/2011
Decision Date02/03/2012
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes to the software for the targis system coolwave control unit model 5000 and associated changes to the user manual. The device,as modified, will be marketed under the trade name urologix targis system and is indicated for the relief of symptoms and obstructions associated with benign prostatic hyperplasia (bph) for men with prostatic urethral lengths of 2. 5-3. 5cm (short antenna), or 3. 0-5. 0cm (standard antenna), or 4. 5+cm (long antenna).
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