PMA P860003S111

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S111
Product code: LNR
Decision date: 2025-02-27
Classification: Gastroenterology, Urology
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for software and labelling changes proposed for the TherakosCellex Photopheresis System to provide adequate instruction and controls for the use of a new anticoagulant (ACD-A) with the Cellex Photopheresis system and change to the materials of the Therakos Cellex Photopheresis procedural kit to remove the plasticizer di(2-ethylhexyl) phthalate, more commonly known as DEHP.

Current openFDA PMA Record#

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S111
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2025-02-27
Decision code: APPR
Date received: 2023-12-12
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for software and labelling changes proposed for the TherakosCellex Photopheresis System to provide adequate instruction and controls for the use of a new anticoagulant (ACD-A) with the Cellex Photopheresis system and change to the materials of the Therakos Cellex Photopheresis procedural kit to remove the plasticizer di(2-ethylhexyl) phthalate, more commonly known as DEHP.