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.
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.
| Device | PROLIEVE THERMODILATATION SYSTEM |
| Classification Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | MEDIFOCUS, INC |
| Date Received | 2003-03-24 |
| Decision Date | 2004-02-19 |
| Notice Date | 2004-03-09 |
| PMA | P030006 |
| Supplement | S |
| Product Code | MEQ |
| Docket Number | 04M-0116 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDIFOCUS, INC 10240 Old Columbia Road suite G columbia, MD 21046 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030006 | Original Filing | |
| S028 | 2018-03-30 | Normal 180 Day Track No User Fee |
| S027 | 2014-11-18 | 30-day Notice |
| S026 | 2014-05-21 | 135 Review Track For 30-day Notice |
| S025 | 2012-04-23 | 30-day Notice |
| S024 | 2010-12-23 | Normal 180 Day Track No User Fee |
| S023 | 2010-01-13 | 30-day Notice |
| S022 | 2009-04-02 | Normal 180 Day Track |
| S021 | 2009-01-16 | 135 Review Track For 30-day Notice |
| S020 | 2008-11-14 | 30-day Notice |
| S019 | 2008-07-01 | Real-time Process |
| S018 | 2008-06-05 | 135 Review Track For 30-day Notice |
| S017 | 2008-02-12 | Normal 180 Day Track |
| S016 | 2007-09-28 | 30-day Notice |
| S015 | 2007-06-14 | 30-day Notice |
| S014 | 2007-06-13 | Real-time Process |
| S013 | 2007-04-23 | Normal 180 Day Track No User Fee |
| S012 | 2006-11-21 | Real-time Process |
| S011 | 2006-06-26 | Real-time Process |
| S010 | 2005-12-01 | Normal 180 Day Track No User Fee |
| S009 | 2005-11-21 | Normal 180 Day Track |
| S008 | 2005-11-18 | Normal 180 Day Track |
| S007 | 2005-09-12 | 30-day Notice |
| S006 | 2005-05-31 | Real-time Process |
| S005 | 2005-03-23 | Normal 180 Day Track No User Fee |
| S004 | 2005-01-28 | Real-time Process |
| S003 | 2004-10-01 | Normal 180 Day Track No User Fee |
| S002 | 2004-08-18 | Real-time Process |
| S001 | 2004-03-11 | Normal 180 Day Track No User Fee |