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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUROLOGIX TARGIS SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametargeted transurethral thermoablation for benign prostatic hyperplasia bph
ApplicantUROLOGIX, INC.
PMA NumberP970008
Supplement NumberS028
Date Received04/28/2005
Decision Date02/06/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the control unit (targis "cool wave" control unit model 5000a or next generation control unit - ngcu), software, and operating modes for both the targis microwave delivery system (mds) and targis cooled thermocath mds.
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