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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 (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Supplement NumberS021
Date Received07/02/2001
Decision Date09/19/2001
Withdrawal Date 12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT VENUSA DE MEXICO S.A. DE C.V, CHIHUAHUA, MEXICO, IN WHICH THE PROSTATRON DISPOSABLE TREATMENT APPLICATOR WILL BE ASSEMBLED. IN ADDITION, APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT VENUSA LTD., EL PASO, TEXAS, FOR THE RECEIPT, INSPECTION, STORAGE, AND RELEASE OF COMPONENTS AND THE QUARANTINE OF FINISHED STERILIZED DEVICES. ALSO, THE APPLICATOR WILL BE STERILIZED AT GRIFFITH MICROSCIENCE, SANTA TERESA, NEW MEXICO.
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