Mallinckrodt Pharmaceuticals Ireland L T D

FDA Filings

This page includes the latest FDA filings for Mallinckrodt Pharmaceuticals Ireland L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013428851
• FEI Number: 3013428851
• Name: MALLINCKRODT PHARMACEUTICALS IRELAND LTD
• Owner & Operator: Mallinckrodt Pharmaceuticals Ireland Ltd
• Contact Address: College Business & Technology Park Cruiserath Road; Blanchardstown IE-D Dublin D15 TX2V IE
• US Agent:
  • Jamie Yieh
  • Mallinckrodt Pharmaceuticals
  • 908 2386738
  • jamie.yieh@mallinckrodt.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: College Business & Technology Park Cruiserath Road; Blanchardstown Dublin, D15 TX2V IE
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMA P860003S105 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA	2021-10-01
PMA P860003S104 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL	2021-10-01
PMA P860003S102 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX Photopheresis System	2020-07-31
PMA P860003S101 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX Procedural Kit	2019-05-13
PMA P860003S100 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX Procedural Kit	2019-01-10
PMA P860003S099 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX Procedural Kit	2018-11-01
PMN P860003 | LNR MALLINCKRODT PHARMACEUTICALS IRELAND LTD	Therakos CELLEX Photopheresis System; UVAR XTS Photopheresis System	2018-03-28
PMA P860003S098 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos Cellex Procedural Kit	2018-03-08
PMA P860003S093 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos Cellex Photopheresis System	2018-01-28
PMA P860003S097 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos Cellex Photopheresis System	2018-01-26
PMA P860003S096 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos Cellex Procedural Kit	2017-10-06
PMA P860003S095 Mallinckrodt Pharmaceuticals Ireland Limited	CELLEX PHOTOPHERESIS SYSTEM	2017-09-14
PMA P860003S094 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX Procedural Kit	2017-08-18
PMA P860003S092 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX Photopheresis Procedural Kit	2017-08-17
PMA P860003S090 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX Photopheresis System	2017-07-21
PMA P860003S089 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos Uvar XTS Photopheresis System Procedural Kit.	2017-05-16
PMA P860003S088 Mallinckrodt Pharmaceuticals Ireland Limited	Therakos CELLEX and UVAR XTS Procedural Kits	2017-05-02
PMA P860003S087 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM, INSTRUMENT, LIGHT ASSEMBLY, PROCEDURAL KIT.	2017-04-27
PMA P860003S086 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS Photopheresis System Procedural Kit	2016-05-05
PMA P860003S085 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	2016-04-22
PMA P860003S083 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT	2016-04-08
PMA P860003S084 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PROCEDURAL KIT	2016-02-25
PMA P860003S082 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT	2016-01-21
PMA P860003S081 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT	2015-11-02
PMA P860003S080 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PROCEDURAL KIT	2015-07-30
PMA P860003S079 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM	2015-04-16
PMA P860003S078 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEXPHOTOPHERESIS SYSTEM	2015-03-19
PMA P860003S077 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM	2015-02-03
PMA P860003S076 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2014-08-21
PMA P860003S075 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS KIT	2014-05-09
PMA P860003S074 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY	2013-08-28
PMA P860003S071 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM	2013-08-08
PMA P860003S073 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY	2013-05-06
PMA P860003S068 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHRESES SYSTEM	2013-05-01
PMA P860003S072 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT	2013-03-20
PMA P860003S070 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2013-02-19
PMA P860003S069 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS	2013-02-15
PMA P860003S067 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,	2012-11-19
PMA P860003S066 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA	2012-11-09
PMA P860003S064 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS	2012-04-04
PMA P860003S065 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM	2012-03-02
PMA P860003S063 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2012-01-10
PMA P860003S062 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEMS	2011-10-28
PMA P860003S061 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2011-09-22
PMA P860003S060 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2011-08-05
PMA P860003S057 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2011-07-29
PMA P860003S059 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT	2011-05-13
PMA P860003S058 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2011-04-21
PMA P860003S055 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PROCEDURAL KIT	2011-01-25
PMA P860003S056 Mallinckrodt Pharmaceuticals Ireland Limited	CELLEX PROCEDURAL KIT	2010-12-09
PMA P860003S054 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX PHOTOPHERESIS SYSTEM	2009-09-15
PMA P860003S053 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS CELLEX* PHOTOPHERESIS SYSTEM	2009-05-27
PMA P860003S048 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR CELLEX PHOTOPHERESIS SYSTEM	2009-03-20
PMA P860003S051 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2009-01-16
PMA P860003S050 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2008-12-19
PMA P860003S049 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM	2008-08-29
PMA P860003S047 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2008-02-01
PMA P860003S045 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2006-12-22
PMA P860003S044 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2006-07-14
PMA P860003S043 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2005-08-19
PMA P860003S042 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2002-12-20
PMA P860003S041 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2002-11-25
PMA P860003S040 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	2002-04-12
PMA P860003S039 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM	2001-05-22
PMA P860003S038 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR(R) XTS(R) PHOTOPHERESIS SYSTEM	2001-02-15
PMA P860003S037 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS(TM) PHOTOPHERESIS SYSTEM	2001-01-05
PMA P860003S036 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	2000-11-22
PMA P860003S033 Mallinckrodt Pharmaceuticals Ireland Limited	UVADEX(R) STERILE LIQUID	2000-03-06
PMA P860003S035 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHORESIS SYSTEM	2000-01-14
PMA P860003S034 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	1999-11-29
PMA P860003S030 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHORESIS SYSTEM	1999-09-07
PMA P860003S031 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	1999-08-10
PMA P860003S032 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR XTS PHOTOPHERESIS SYSTEM	1998-09-01
PMA P860003S029 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHORESIS SYSTEM	1998-02-26
PMA P860003S028 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHORESIS SYSTEM	1997-03-25
PMA P860003S025 Mallinckrodt Pharmaceuticals Ireland Limited	THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM	1996-10-03
PMA P860003S027 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHORESIS SYSTEM	1996-05-17
PMA P860003S024 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHORESIS SYSTEM	1995-05-18
PMA P860003S023 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHORESIS SYSTEM	1995-01-26
PMA P860003S020 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1993-12-07
PMA P860003S022 Mallinckrodt Pharmaceuticals Ireland Limited	TPS 101 PHOTOPHERESIS BLOOD TUBING SET	1992-06-19
PMA P860003S021 Mallinckrodt Pharmaceuticals Ireland Limited	TPS 102 PHOTOCEPTOR ACTIVATION CHAMBER	1992-06-19
PMA P860003S019 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING	1991-03-11
PMA P860003S018 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING	1991-02-13
PMA P860003S017 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1990-12-13
PMA P860003S012 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1990-02-23
PMA P860003S014 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1990-01-26
PMA P860003S013 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1989-12-22
PMA P860003S011 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1989-04-12
PMA P860003S006 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1988-12-29
PMA P860003S010 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1988-12-28
PMA P860003S009 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1988-10-07
PMA P860003S008 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1988-06-30
PMA P860003S007 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1988-06-17
PMA P860003S005 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1988-02-10
PMA P860003S004 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1987-11-06
PMA P860003S003 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1987-11-06
PMA P860003S002 Mallinckrodt Pharmaceuticals Ireland Limited	UVAR PHOTOPHERESIS SYSTEM	1987-09-09

Similar & Related FDA Registered Companies

• 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
• Mallinckrodt 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
• 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