Approval for moving production of the ballast monitor pcba and bracket assembly from eas to new supplier saline lectronics
| Device | THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA |
| Generic Name | System, Photopheresis, Extracorporeal |
| Applicant | Mallinckrodt Pharmaceuticals Ireland Limited |
| Date Received | 2021-09-03 |
| Decision Date | 2021-10-01 |
| PMA | P860003 |
| Supplement | S105 |
| Product Code | LNR |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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