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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 NamePROSTATRON
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave therotherapy (tumt)
ApplicantUROLOGIX, INC.
PMA NumberP950014
Supplement NumberS023
Date Received09/30/2004
Decision Date02/18/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the prostatron labeling regarding the treatment of patients 1) with implanted active devices (including pacemakers and defibrillators), 2) in urinary retention, and 3) with median prostatic lobes.
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