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 modification of the user manual as revision e.
| Device | PROLIEVE THERMODILATATION SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | MEDIFOCUS, INC |
| Date Received | 2007-06-13 |
| Decision Date | 2007-07-03 |
| PMA | P030006 |
| Supplement | S014 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |