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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 NumberS024
Date Received12/23/2010
Decision Date05/13/2011
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Post-Approval StudyShow Report Schedule and Study Progress
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