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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 NumberS036
Date Received01/31/2008
Decision Date03/31/2008
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the materials, color, antenna design, coolant path functions and design of the cooled thermocath catheter. The device, as modified, will be marketed under the trade name ctc advance and is indicated to relieve symptoms and obstruction associated with benign prostatic hyperplasia (bph) and is indicated for men with prostatic urethra lengths of 3. 5 ? 5. 0 cm (model number tc1121c) or 4. 5+ cm (model number tf1221c).
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