Approval for engineering and design changes to the uvar xtsphotopheresis system. The device, as modified, will be marketed under the trade nametherakos cellex photopheresis system, and is indicated for use in the ultraviolet-a(uva) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-mop), ofextracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skinmanifestations of cutaneous t-cell lymphoma (ctcl), in persons who have not been responsive to other forms of treatment.
| Device | UVAR CELLEX PHOTOPHERESIS SYSTEM |
| Classification Name | System, Photopheresis, Extracorporeal |
| Generic Name | System, Photopheresis, Extracorporeal |
| Applicant | Mallinckrodt Pharmaceuticals Ireland Limited |
| Date Received | 2008-06-11 |
| Decision Date | 2009-03-20 |
| PMA | P860003 |
| Supplement | S048 |
| Product Code | LNR |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| 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