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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.
 
DeviceUROLOGIX PROSTATRON SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Supplement NumberS026
Date Received03/14/2008
Decision Date07/16/2008
Withdrawal Date 12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN MODIFICATIONS WHICH INCLUDE A NEW CATHETER TIP MATERIAL, RED MARK ADHESIVE, BONDING ADHESIVES, INJECTION MOLD FOR MANUFACTURING THE CATHETER TIP, AND A NEW STERILE BALLOON INFLATION STOPCOCK. THE PRODUCTION OF THE PROSTAPROBE TYPE II, SILICONE, BLUE TREATMENT CATHETER (PART NUMBER 410053-004) WILL BE MANUFACTURED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA.
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