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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.
 
DevicePROLIEVE THERMODILITATION SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantMEDIFOCUS, INC
10240 OLD COLUMBIA ROAD
SUITE G
COLUMBIA, MD 21046
PMA NumberP030006
Supplement NumberS021
Date Received01/16/2009
Decision Date06/19/2009
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE WELDING PROCESS THAT IS USED TO BOND THE CATHETER TIP TO THE CATHETER EXTRUSION FOR THE PROLIEVE TREATMENT CATHETER.
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