PMA P860003S110

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S110
Product code: LNR
Decision date: 2023-08-10
Classification: Gastroenterology, Urology
Generic name: System, photopheresis, extracorporeal
Approval order statement: Change to qualify a new core for the drive tube injection mold tool used to manufacture the O-ring sealing gland of the THERAKOS® CELLEX® Procedural Kit, which will also alter the cavity insert for the molding process from P20 Tool Steel to S7 Tool Steel, and improve production readiness.

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: S110
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2023-08-10
Decision code: OK30
Date received: 2023-07-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to qualify a new core for the drive tube injection mold tool used to manufacture the O-ring sealing gland of the THERAKOS® CELLEX® Procedural Kit, which will also alter the cavity insert for the molding process from P20 Tool Steel to S7 Tool Steel, and improve production readiness.