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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 NameUROLOGIC 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 NumberS002
Date Received09/05/1997
Decision Date01/09/1998
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at seamed corp. , 21621 30th ave. , ne, bothell, wa 98021.
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