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.
Approval for software modifications including adjustment of tolerance limits. The device, as modified, will be marketed under the trade name prolieve thermodilation system (prolieve). Prolieve is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic bph 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) is typically indicated.
| Device | CELSION PROLIEVE THERMODILATATION SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | MEDIFOCUS, INC |
| Date Received | 2004-08-18 |
| Decision Date | 2004-09-17 |
| PMA | P030006 |
| Supplement | S002 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDIFOCUS, INC 10240 Old Columbia Road suite G columbia, MD 21046 |
| 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 |