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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROLIEVE THERMODILATATION SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy(tumt) device
ApplicantMEDIFOCUS, INC
PMA NumberP030006
Date Received03/24/2003
Decision Date02/19/2004
Product Code
MEQ[ Registered Establishments with MEQ ]
Docket Number 04M-0116
Notice Date 03/09/2004
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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