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 design changes to include changing the contacts on the internal wiring from tin to gold and a modification to the software to include an additional alarm. The device, as modified, will be marketed under the trade name prostatron praktis and is indicated for the treatment of benign prostatic hyperplasia (bph).
| Device | PROSTATRON PRAKTIS |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Urologix, Inc. |
| Date Received | 2004-05-17 |
| Decision Date | 2004-06-10 |
| PMA | P950014 |
| Supplement | S022 |
| 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 | 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 |