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 longer version of the cooled thermocath microwave delivery catheter. The longer antenna is 37 mm compared to the 28 mm antenna in the currently approved cooled thermocath catheter. The device, as modified, will be marketed under the trade name cooled thermocath 4. 5+ and is indicated for men with prostatic urethral lengths of 4. 5 cm or greater.
| 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 | 2005-02-25 |
| Decision Date | 2005-06-16 |
| PMA | P970008 |
| Supplement | S026 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| 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 |