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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROSTATRON
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nameprostate (bph) microwave apparatus
ApplicantUROLOGIX, INC.
PMA NumberP950014
Date Received04/17/1995
Decision Date05/03/1996
Product Code
MEQ[ Registered Establishments with MEQ ]
Docket Number 96M-0358
Notice Date 10/09/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
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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