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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
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Urologix, Inc.
14405 21st avenue n.
minneapolis, MN 55447-2000
PMA NumberP950014
Supplement NumberS021
Date Received07/02/2001
Decision Date09/19/2001
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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