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.
Device | THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO |
Generic Name | System, Photopheresis, Extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS106 Date Received02/09/2022 Decision Date03/11/2022 Product Code LNR Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-02-09 |
Decision Date | 2022-03-11 |
PMA | P860003 |
Supplement | S106 |
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 PMA NumberP860003 Supplement NumberS106 Date Received02/09/2022 Decision Date03/11/2022 Product Code LNR Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement is For Moving The Moulding Production Of The Y-Fitting Adapter Component From Harmac Buffalo, NY, USA Site To Harmac Castlerea, Republic Of Ireland Site To Improve Moulding Capacity And Component Supply |
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 |
Device ID | PMA | Supp |
---|---|---|
30705030000013 | P860003 | 074 |
30705030000006 | P860003 | 074 |