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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROSTATRON
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Supplement NumberS004
Date Received10/25/1996
Decision Date10/29/1996
Withdrawal Date 12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
UPGRADES IN 1)THE LUXTRON THERMOMETRY UNIT FROM MODEL 3000-4 TO MODEL 3100; 2) THE COMPUTER PROCESSOR FROM 386 TO PENTIUM; AND 3) THE SOFTWARE FROM VERSION 3.07 TO VERSION 3.09
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