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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 NumberS025
Date Received02/01/2005
Decision Date02/15/2005
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 the following changes to the device: 1) the change of the insertion tip and adhesive of the cooled thermocath microwave delivery system (ctc mds) to increase to the flexibility of the catheter; 2) the change of the insertion tip and adhesive of the targis microwave delivery system to the same catheter type as the ctc mds; and 3) the addition of texin 950 uv stabilized tubing for the shaft of the ctc catheter.
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