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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 NumberS022
Date Received07/05/2002
Decision Date08/01/2002
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE OF SUPPLIER FOR THE FIBER OPTIC TEMPERATURE SENSOR PROBE COMPONENT FROM THE LUXTRON CORPORATION IN SANTA CLARA, CALIFORNIA TO THE UROLOGIX FACILITY AND A CHANGE IN THE USE OF AN ADHESIVE BONDING PROCESS TO AN ANNEALING PROCESS ON THE COOLANT BAG.
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