Approval for a labeling change to reflect the use of uvadex, the sterile liqud formulation of 8-methoxypsoralen.
Device | UVADEX(R) STERILE LIQUID |
Classification Name | System, Photopheresis, Extracorporeal |
Generic Name | System, Photopheresis, Extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited |
Date Received | 1999-09-07 |
Decision Date | 2000-03-06 |
PMA | P860003 |
Supplement | S033 |
Product Code | LNR |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | Normal 180 Day 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