PMA P860003S106

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S106
Product code: LNR
Decision date: 2022-03-11
Generic name: System, photopheresis, extracorporeal
Approval order statement: 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.

Current openFDA PMA Record#

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S106
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2022-03-11
Decision code: OK30
Date received: 2022-02-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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.