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 the materials, color, antenna design, coolant path functions and design of the cooled thermocath catheter. The device, as modified, will be marketed under the trade name ctc advance and is indicated to relieve symptoms and obstruction associated with benign prostatic hyperplasia (bph) and is indicated for men with prostatic urethra lengths of 3. 5? 5. 0 cm (model number tc1121c) or 4. 5+ cm (model number tf1221c).
| Device | UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH |
| Classification Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Generic Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Applicant | Urologix, LLC |
| Date Received | 2008-01-31 |
| Decision Date | 2008-03-31 |
| PMA | P970008 |
| Supplement | S036 |
| 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, 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 |