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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUROLOGIX TARGIS SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, LLC
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP970008
Supplement NumberS018
Date Received12/03/2001
Decision Date09/04/2002
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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