THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS

FDA Premarket Approval P860003 S107

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

DeviceTHERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS
Generic NameSystem, Photopheresis, Extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS107 Date Received04/27/2022 Decision Date05/25/2022 Product Code LNR  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-27
Decision Date2022-05-25
PMAP860003
SupplementS107
Product CodeLNR 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressMallinckrodt Pharmaceuticals Ireland Limited
college Business & Technology Park
cruiserath Road
blanchardstown D15 T PMA NumberP860003 Supplement NumberS107 Date Received04/27/2022 Decision Date05/25/2022 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  
This Submission Requests Qualification Of A Mold Tool With A Material Change For The Core Insert. The Change Is Being Made For Improving Production Readiness. The Information Dimensional Verification And Process Verification Provided By The Sponsor Is Acceptable.

Supplemental Filings

Supplement NumberDateSupplement Type
P860003Original Filing
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

Device IDPMASupp
30705030000013 P860003 074
30705030000006 P860003 074

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