Device Dossier
Photopheresis system
Device Dossier for Photopheresis system (Photopheresis system, Class IIb, sponsor Therakos). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Photopheresis system
- Sponsor: Therakos
Intended purpose
The THERAKOS™ CELLEX™ Photopheresis System is indicated to be used: For patients older than 18 years of age for the administration of photopheresis in the following: Cutaneous T Cell Lymphoma (CTCL) Solid Organ Transplant Rejection (SOT)(heart, lung) and For patients older than 3 years of age for the management of Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD).