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 a new ink to be used to mark the catheter component of the device using the same pad printing process for applying these markings.
| Device | PROLIEVE THERMODILATATION SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | MEDIFOCUS, INC |
| Date Received | 2005-01-28 |
| Decision Date | 2005-03-11 |
| PMA | P030006 |
| Supplement | S004 |
| 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 |