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 NumberS108 Date Received08/26/2022 Decision Date09/23/2022 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 | 2022-08-26 |
| Decision Date | 2022-09-23 |
| PMA | P860003 |
| Supplement | S108 |
| 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 NumberS108 Date Received08/26/2022 Decision Date09/23/2022 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 a Change In The Manufacturing Process Of The American RENOLIT PVC Film Used In The Cellex Procedural Kit And Treatment And Return Bags. |
| 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 |