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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePROSTATRON
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Date Received04/17/1995
Decision Date05/03/1996
Withdrawal Date 12/30/2014
Product Code MEQ 
Docket Number 96M-0358
Notice Date 10/09/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR PROSTATRON
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 
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