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 changes to shelf box label, sterile use of a new electrical safety test on prolieve consoles.
| Device | PROLIEVE THERMODILITATION SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | MEDIFOCUS, INC |
| Date Received | 2010-01-13 |
| Decision Date | 2010-02-12 |
| PMA | P030006 |
| Supplement | S023 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |