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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 PRAKTIS
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21st Ave. N
Plymouth, MN 55447
PMA NumberP950014
Supplement NumberS019
Date Received11/02/1999
Decision Date11/05/1999
Withdrawal Date12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.
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