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.
Change of supplier for the fiber optic temperature sensor probe component from the luxtron corporation in santa clara, california to the urologix facility and a change in the use of an adhesive bonding process to an annealing process on the coolant bag.
| Device | UROLOGIX TARGIS SYSTEM |
| 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 | 2002-07-05 |
| Decision Date | 2002-08-01 |
| PMA | P970008 |
| Supplement | S022 |
| Product Code | MEQ |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |