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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 NumberS018
Date Received12/03/2001
Decision Date09/04/2002
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 a change from the standard antenna (2. 8 cm in length) to a shortened version (2. 0 cm in length). The device, as modified, will be marketed under the trade name urologix targis system, and is intended to relieve symptoms and obstruction associated with benign prostatic hyperplasmia (bph), and is indicated for men with prostatic urethra lengths of 2. 5 to 3. 5 cm.
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