THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL

FDA Premarket Approval P860003 S104

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.

Pre-market Approval Supplement Details

Approval for moving production of the servo isolation module pcba (printed circuit board assembly) assembly (pn-1260019) from eas to a new supplier, saline lectronics

DeviceTHERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL
Generic NameSystem, Photopheresis, Extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
Date Received2021-09-03
Decision Date2021-10-01
PMAP860003
SupplementS104
Product CodeLNR 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Mallinckrodt Pharmaceuticals Ireland Limited college Business & Technology Park cruiserath Road blanchardstown D15 T

Supplemental Filings

Supplement NumberDateSupplement Type
P860003Original Filing
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

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