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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 NumberS029
Date Received05/10/2005
Decision Date03/23/2006
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A RADIO FREQUENCY IDENTIFICATION (RFID) SYSTEM TO PREVENT REUSE OF THE DISPOSABLE DEVICE COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE DELIVERY OF MICROWAVE ENERGY TO THE PROSTATE FOR THE TREATMENT OF BPH IN A SINGLE SESSION. IT IS INDICATED FOR PATIENTS WITH PROSTATIC LENGTHS OF 30 TO 50 MM.
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