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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.
 
DeviceUROLOGIC TARGIS SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, LLC
14405 21st Ave. N
Plymouth, MN 55447
PMA NumberP970008
Supplement NumberS004
Date Received11/21/1997
Decision Date11/26/1997
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the physician training manual for the addition of a module for patient comfort management.
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