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 prostatron labeling regarding the treatment of patients 1) with implanted active devices (including pacemakers and defibrillators), 2) in urinary retention, and 3) with median prostatic lobes.
| Device | PROSTATRON |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Urologix, Inc. |
| Date Received | 2004-09-30 |
| Decision Date | 2005-02-18 |
| PMA | P950014 |
| Supplement | S023 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Urologix, Inc. 14405 21st Avenue N. minneapolis, MN 55447-2000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950014 | Original Filing | |
| S026 | 2008-03-14 | Normal 180 Day Track |
| S025 | ||
| S024 | 2005-01-19 | Real-time Process |
| S023 | 2004-09-30 | Normal 180 Day Track |
| S022 | 2004-05-17 | Real-time Process |
| S021 | 2001-07-02 | Normal 180 Day Track |
| S020 | 1999-11-26 | Normal 180 Day Track |
| S019 | 1999-11-02 | Real-time Process |
| S018 | 1999-05-17 | Real-time Process |
| S017 | 1999-01-13 | Real-time Process |
| S016 | 1998-06-25 | Normal 180 Day Track |
| S015 | 1998-07-14 | Normal 180 Day Track |
| S014 | 1998-06-09 | Real-time Process |
| S013 | 1998-03-04 | Real-time Process |
| S012 | 1998-01-14 | Real-time Process |
| S011 | 1997-12-31 | Normal 180 Day Track |
| S010 | 1997-10-01 | Real-time Process |
| S009 | 1997-09-18 | Real-time Process |
| S008 | 1997-08-28 | Normal 180 Day Track |
| S007 | 1997-08-06 | Normal 180 Day Track |
| S006 | 1997-04-07 | Normal 180 Day Track |
| S005 | 1996-10-31 | Special (immediate Track) |
| S004 | 1996-10-25 | Real-time Process |
| S003 | 1996-09-23 | Normal 180 Day Track |
| S002 | 1996-07-24 | Normal 180 Day Track |
| S001 | 1996-05-16 | Normal 180 Day Track |