Approval for a labeling change (inclusion of an additional warning) to address the potential for the development of hypovolemia and hypotension during photopheresis treatments in patients with elevated triglyceride levels (hyperlipidemia), such as patients receiving certain cutaneous t-cell lymphoma drugs, like targretin. (bexarotene).
| Device | UVAR XTS PHOTOPHERESIS SYSTEM |
| Classification Name | System, Photopheresis, Extracorporeal |
| Generic Name | System, Photopheresis, Extracorporeal |
| Applicant | Mallinckrodt Pharmaceuticals Ireland Limited |
| Date Received | 2002-03-15 |
| Decision Date | 2002-04-12 |
| PMA | P860003 |
| Supplement | S040 |
| Product Code | LNR |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Mallinckrodt Pharmaceuticals Ireland Limited college Business & Technology Park cruiserath Road blanchardstown D15 T |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P860003 | | Original Filing |
| S108 |
2022-08-26 |
30-day Notice |
| S107 |
2022-04-27 |
30-day Notice |
| S106 |
2022-02-09 |
30-day Notice |
| S105 |
2021-09-03 |
30-day Notice |
| S104 |
2021-09-03 |
30-day Notice |
| S103 | | |
| S102 |
2020-02-03 |
Normal 180 Day Track |
| S101 |
2019-02-12 |
Real-time Process |
| S100 |
2018-12-13 |
30-day Notice |
| S099 |
2018-10-01 |
30-day Notice |
| S098 |
2018-02-07 |
30-day Notice |
| S097 |
2017-10-30 |
Real-time Process |
| S096 |
2017-09-08 |
30-day Notice |
| S095 |
2017-08-16 |
30-day Notice |
| S094 |
2017-07-24 |
30-day Notice |
| S093 |
2017-07-10 |
Normal 180 Day Track No User Fee |
| S092 |
2017-06-12 |
Real-time Process |
| S091 | | |
| S090 |
2017-05-22 |
Real-time Process |
| S089 |
2017-04-17 |
30-day Notice |
| S088 |
2017-04-03 |
30-day Notice |
| S087 |
2016-05-18 |
Normal 180 Day Track |
| S086 |
2016-04-08 |
30-day Notice |
| S085 |
2016-03-24 |
30-day Notice |
| S084 |
2016-01-28 |
30-day Notice |
| S083 |
2016-01-12 |
Real-time Process |
| S082 |
2015-12-24 |
30-day Notice |
| S081 |
2015-08-04 |
Real-time Process |
| S080 |
2015-07-02 |
30-day Notice |
| S079 |
2015-03-13 |
30-day Notice |
| S078 |
2015-02-19 |
30-day Notice |
| S077 |
2014-11-12 |
Real-time Process |
| S076 |
2014-07-25 |
30-day Notice |
| S075 |
2014-02-10 |
Real-time Process |
| S074 |
2013-06-03 |
Real-time Process |
| S073 |
2013-04-09 |
30-day Notice |
| S072 |
2013-03-08 |
30-day Notice |
| S071 |
2013-02-22 |
Normal 180 Day Track |
| S070 |
2013-01-24 |
30-day Notice |
| S069 |
2013-01-14 |
Special (immediate Track) |
| S068 |
2012-11-06 |
Normal 180 Day Track |
| S067 |
2012-09-27 |
Real-time Process |
| S066 |
2012-09-10 |
Real-time Process |
| S065 |
2012-02-01 |
Special (immediate Track) |
| S064 |
2012-01-24 |
Special (immediate Track) |
| S063 |
2011-12-12 |
30-day Notice |
| S062 |
2011-09-29 |
Special (immediate Track) |
| S061 |
2011-08-26 |
30-day Notice |
| S060 |
2011-07-06 |
30-day Notice |
| S059 |
2011-03-14 |
Real-time Process |
| S058 |
2011-03-08 |
Normal 180 Day Track No User Fee |
| S057 |
2011-01-31 |
Normal 180 Day Track |
| S056 |
2010-11-12 |
30-day Notice |
| S055 |
2010-09-01 |
135 Review Track For 30-day Notice |
| S054 |
2009-06-17 |
135 Review Track For 30-day Notice |
| S053 |
2009-04-28 |
30-day Notice |
| S052 | | |
| S051 |
2008-12-18 |
30-day Notice |
| S050 |
2008-11-18 |
30-day Notice |
| S049 |
2008-06-23 |
Real-time Process |
| S048 |
2008-06-11 |
Normal 180 Day Track |
| S047 |
2007-12-03 |
Real-time Process |
| S046 | | |
| S045 |
2006-11-22 |
Real-time Process |
| S044 |
2006-06-14 |
Special (immediate Track) |
| S043 |
2005-07-21 |
Real-time Process |
| S042 |
2002-11-26 |
30-day Notice |
| S041 |
2002-04-01 |
Normal 180 Day Track |
| S040 |
2002-03-15 |
Special (immediate Track) |
| S039 |
2001-03-05 |
Real-time Process |
| S038 |
2001-01-31 |
30-day Notice |
| S037 |
2000-07-07 |
Normal 180 Day Track |
| S036 |
2000-05-25 |
Normal 180 Day Track |
| S035 |
1999-12-20 |
Normal 180 Day Track |
| S034 |
1999-11-05 |
30-day Notice |
| S033 |
1999-09-07 |
Normal 180 Day Track |
| S032 |
1998-08-26 |
Real-time Process |
| S031 |
1998-08-05 |
Normal 180 Day Track |
| S030 |
1998-04-29 |
Normal 180 Day Track |
| S029 |
1997-09-11 |
Normal 180 Day Track |
| S028 |
1997-01-30 |
|
| S027 |
1995-10-05 |
Normal 180 Day Track |
| S026 | | |
| S025 |
1995-02-09 |
Normal 180 Day Track |
| S024 |
1994-10-26 |
Normal 180 Day Track |
| S023 |
1993-05-10 |
Normal 180 Day Track |
| S022 |
1991-12-16 |
Normal 180 Day Track |
| S021 |
1991-11-27 |
Normal 180 Day Track |
| S020 |
1991-09-06 |
Normal 180 Day Track |
| S019 |
1990-09-12 |
Normal 180 Day Track |
| S018 |
1990-08-20 |
Normal 180 Day Track |
| S017 |
1990-07-09 |
Normal 180 Day Track |
| S016 | | |
| S015 | | |
| S014 |
1989-12-20 |
Normal 180 Day Track |
| S013 |
1989-06-06 |
Normal 180 Day Track |
| S012 |
1989-05-26 |
Normal 180 Day Track |
| S011 |
1989-03-24 |
Normal 180 Day Track |
| S010 |
1988-11-17 |
Normal 180 Day Track |
| S009 |
1988-08-29 |
Normal 180 Day Track |
| S008 |
1988-06-17 |
Normal 180 Day Track |
| S007 |
1988-05-25 |
Normal 180 Day Track |
| S006 |
1988-05-11 |
Normal 180 Day Track |
| S005 |
1988-01-20 |
Normal 180 Day Track |
| S004 |
1987-09-22 |
Normal 180 Day Track |
| S003 |
1987-09-09 |
Normal 180 Day Track |
| S002 |
1987-08-04 |
Normal 180 Day Track |
| S001 |
1987-04-07 |
Normal 180 Day Track |
NIH GUDID Devices