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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.
 
DeviceTARGIS SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, LLC
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP970008
Supplement NumberS033
Date Received07/11/2007
Decision Date04/15/2008
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA FOR THE MANUFACTURING OF THE COOLANT BAG KITS.
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