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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 FOR THE TREATMENT OF BPH
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Urologix, LLC
14405 21st avenue n.
minneapolis, MN 55447-2000
PMA NumberP970008
Supplement NumberS031
Date Received02/20/2007
Decision Date03/19/2007
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE THE RECTAL THERMOSENSING UNIT (RTU) PLUS TEMPERATURE SENSOR CHANNEL WIDTH AND WELD THE T-WELD CORNERS WITH A GRADUAL RADIUS TURN.
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