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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 NumberS024
Date Received01/19/2005
Decision Date02/23/2005
Withdrawal Date 12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO CHANGE LOCATION BALLOON MATERIAL FROM LATEX TO SILICONE, TO CHANGE THE METHOD OF ATTACHING THE LOCATION BALLOON DUE TO THE NEW MATERIAL, AND TO REMOVE THE CURRENT LATEX SENSITIVITY CAUTION AND OTHER REFERENCES TO LATEX IN THE LABELING.
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