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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 Ave. N
Plymouth, MN 55447
PMA NumberP970008
Supplement NumberS052
Date Received07/02/2010
Decision Date08/27/2010
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) MODIFICATION OF THE RFID PROGRAMMING; 2) MODIFICATION OF THE COIL GAP MEASUREMENT; 3) ADDITION OF A COOLING SYSTEM GASKET; 4) SUBSTITUTION OF A LOCK SCREW; AND 5) SOFTWARE UPDATED TO DIFFERENTIATE CATHETER MODELS, CLOSE ERROR MESSAGES ON RESTART, AND ADD A PRECONFIGURED CONTROL UNIT PROTOCOL SETTING.
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