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 to change location balloon material from latex to silicone, to change the method of attaching the location balloon due to the new material, and to remove the current latex sensitivity caution and other references to latex in the labeling.
| Device | PROSTATRON |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Urologix, Inc. |
| Date Received | 2005-01-19 |
| Decision Date | 2005-02-23 |
| PMA | P950014 |
| Supplement | S024 |
| 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 | 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 |