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 in the supplier of solder used in the manufacture of the targis short catheter.
| Device | UROLOGIX TARGIS SYSTEM FOT 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 | 2010-07-02 |
| Decision Date | 2010-07-16 |
| PMA | P970008 |
| Supplement | S051 |
| 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 |