PMA P860003S107

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S107
Product code: LNR
Decision date: 2022-05-25
Generic name: System, photopheresis, extracorporeal
Approval order statement: Qualification of a mold tool with a material change for the core insert. The change is being made for improving production readiness.

Current openFDA PMA Record#

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S107
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2022-05-25
Decision code: OK30
Date received: 2022-04-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of a mold tool with a material change for the core insert. The change is being made for improving production readiness.