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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 AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Supplement NumberS022
Date Received05/17/2004
Decision Date06/10/2004
Withdrawal Date 12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO INCLUDE CHANGING THE CONTACTS ON THE INTERNAL WIRING FROM TIN TO GOLD AND A MODIFICATION TO THE SOFTWARE TO INCLUDE AN ADDITIONAL ALARM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROSTATRON PRAKTIS AND IS INDICATED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).
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