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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 NumberS060
Date Received12/20/2011
Decision Date02/03/2012
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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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