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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 NumberS023
Date Received01/09/2003
Decision Date07/07/2003
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 1) THE RTU PLUS, A MODIFIED VERSION OF THE RECTAL THERMOSENSING UNIT (RTU), AND 2) LABELING CHANGES. THE RTU PLUS INCLUDES A DISPOSABLE BALLOON AND REUSABLE HANDLE, AND WILL BE AVAILABLE AS AN ALTERNATIVE TO THE EXISTING SINGLE USE RTU.
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