PMA P860003S109

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S109
Product code: LNR
Decision date: 2023-03-13
Classification: Gastroenterology, Urology
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for a new fixture to replace the current leak tester.

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: S109
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2023-03-13
Decision code: APPR
Date received: 2022-11-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new fixture to replace the current leak tester.