Premarket Approval (PMA)

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.

• Device: PROLIEVE THERMODILATATION SYSTEM
• Generic Name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
• Applicant: Medifocus, Inc.; 10240 Old Columbia Rd.; Suite G; Columbia, MD 21046
• PMA Number: P030006
• Date Received: 03/24/2003
• Decision Date: 02/19/2004
• Product Code: MEQ
• Docket Number: 04M-0116
• Notice Date: 03/09/2004
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S024 S003 S004 S005 S001 S002 S019 S008 S009 S010 S018 ; S016 S007 S006 S011 S017 S021 S020 S012 S022 S028 S013 S014 ; S015 S023 S025 S027 S026