PMA P860003S113

Device: THERAKOS® CELLEX® Photopheresis System Procedural Kit
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S113
Product code: LNR
Decision date: 2025-06-30
Classification: Gastroenterology, Urology
Generic name: System, photopheresis, extracorporeal
Approval order statement: This 30-Day Notice is to update the Outer Bowl Cover specification to include a flash specification and to implement a Quality Control inspection process for excess flash at CMO (Harmac) of the THERAKOS® CELLEX® Photopheresis System Procedural Kit from Therakos Development Limited.

Current openFDA PMA Record#

Device: THERAKOS® CELLEX® Photopheresis System Procedural Kit
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S113
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2025-06-30
Decision code: OK30
Date received: 2025-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: This 30-Day Notice is to update the Outer Bowl Cover specification to include a flash specification and to implement a Quality Control inspection process for excess flash at CMO (Harmac) of the THERAKOS® CELLEX® Photopheresis System Procedural Kit from Therakos Development Limited.