- Device
- THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S105
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2021-10-01
- Decision code
- OK30
- Date received
- 2021-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving production of the Ballast Monitor PCBA and Bracket Assembly from EAS to new supplier Saline Lectronics.