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 a change in trade name. The device will be marketed under the trade anme urologix targis(tm) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (bph) in ment with prostatic lengths of 30 to 50 millimeters.
| Device | UROLOGIX TARGIS SYSTEM |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Urologix, LLC |
| Date Received | 1997-08-26 |
| Decision Date | 1997-08-28 |
| PMA | P970008 |
| Supplement | S001 |
| 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, LLC 14405 21st Avenue N. minneapolis, MN 55447-2000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970008 | Original Filing | |
| S065 | 2015-09-10 | Normal 180 Day Track No User Fee |
| S064 | 2015-06-23 | Real-time Process |
| S063 | 2013-02-08 | 30-day Notice |
| S062 | 2012-12-10 | 30-day Notice |
| S061 | 2012-02-13 | 30-day Notice |
| S060 | 2011-12-20 | Real-time Process |
| S059 | 2011-09-28 | 30-day Notice |
| S058 | 2011-07-01 | Normal 180 Day Track |
| S057 | ||
| S056 | 2011-04-04 | 30-day Notice |
| S055 | 2011-02-03 | 30-day Notice |
| S054 | ||
| S053 | 2010-11-16 | Real-time Process |
| S052 | 2010-07-02 | Real-time Process |
| S051 | 2010-07-02 | 30-day Notice |
| S050 | 2010-03-19 | 30-day Notice |
| S049 | 2010-03-17 | Real-time Process |
| S048 | 2010-03-03 | Real-time Process |
| S047 | 2010-03-02 | 30-day Notice |
| S046 | 2009-09-23 | 30-day Notice |
| S045 | 2009-07-14 | Real-time Process |
| S044 | 2009-06-02 | 30-day Notice |
| S043 | 2009-02-03 | 30-day Notice |
| S042 | 2008-12-30 | 30-day Notice |
| S041 | 2008-11-17 | 30-day Notice |
| S040 | 2008-10-10 | 30-day Notice |
| S039 | 2008-03-24 | 30-day Notice |
| S038 | 2008-03-10 | Normal 180 Day Track |
| S037 | 2008-02-11 | Real-time Process |
| S036 | 2008-01-31 | Real-time Process |
| S035 | 2008-01-09 | Real-time Process |
| S034 | 2007-10-17 | Normal 180 Day Track |
| S033 | 2007-07-11 | Normal 180 Day Track No User Fee |
| S032 | ||
| S031 | 2007-02-20 | 30-day Notice |
| S030 | 2005-11-21 | Normal 180 Day Track |
| S029 | 2005-05-10 | Normal 180 Day Track |
| S028 | 2005-04-28 | Real-time Process |
| S027 | 2005-04-07 | Real-time Process |
| S026 | 2005-02-25 | Normal 180 Day Track |
| S025 | 2005-02-01 | Real-time Process |
| S024 | 2004-09-30 | Normal 180 Day Track |
| S023 | 2003-01-09 | Normal 180 Day Track |
| S022 | 2002-07-05 | 30-day Notice |
| S021 | 2002-06-21 | Normal 180 Day Track |
| S020 | 2002-03-29 | Real-time Process |
| S019 | 2002-02-04 | Normal 180 Day Track |
| S018 | 2001-12-03 | Normal 180 Day Track |
| S017 | 2001-05-24 | Real-time Process |
| S016 | 2001-02-21 | Normal 180 Day Track |
| S015 | 2000-11-22 | Normal 180 Day Track |
| S014 | 2000-01-19 | Normal 180 Day Track |
| S013 | 1999-12-16 | Normal 180 Day Track |
| S012 | 1999-06-25 | Normal 180 Day Track |
| S011 | 1999-02-16 | Normal 180 Day Track |
| S010 | 1999-02-16 | Real-time Process |
| S009 | 1998-10-21 | Real-time Process |
| S008 | 1998-07-09 | Real-time Process |
| S007 | 1998-06-30 | Real-time Process |
| S006 | 1998-05-05 | Normal 180 Day Track |
| S005 | 1998-02-12 | Real-time Process |
| S004 | 1997-11-21 | Real-time Process |
| S003 | 1997-10-22 | Real-time Process |
| S002 | 1997-09-05 | Normal 180 Day Track |
| S001 | 1997-08-26 | Normal 180 Day Track |