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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
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, LLC
14405 21st Ave. N
Plymouth, MN 55447
PMA NumberP970008
Supplement NumberS025
Date Received02/01/2005
Decision Date02/15/2005
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 THE FOLLOWING CHANGES TO THE DEVICE: 1) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE COOLED THERMOCATH MICROWAVE DELIVERY SYSTEM (CTC MDS) TO INCREASE TO THE FLEXIBILITY OF THE CATHETER; 2) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE TARGIS MICROWAVE DELIVERY SYSTEM TO THE SAME CATHETER TYPE AS THE CTC MDS; AND 3) THE ADDITION OF TEXIN 950 UV STABILIZED TUBING FOR THE SHAFT OF THE CTC CATHETER.
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