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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePROLIEVE THERMODILATATION SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantMEDIFOCUS, INC
10240 OLD COLUMBIA ROAD
SUITE G
COLUMBIA, MD 21046
PMA NumberP030006
Date Received03/24/2003
Decision Date02/19/2004
Product Code MEQ 
Docket Number 04M-0116
Notice Date 03/09/2004
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL THE PROLIEVE THERMODILATATION SYSTEM, WHICH IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BHP IN MEN WITH A PROSTATE SIZE OF 20 TO 80 GRAMS, A PROSTATIC URETHRA LENGTH OF 1.2 TO 5.5 CM AND IN WHOM DRUG THERAPY (E.G., PROSCAR) IN TYPICALLY INDICATED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 
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