PMA P860003S103
- Device
- Therakos CELLEX Photopheresis Kit
- Applicant
- Therakos Development Limited
- Product code
- LNR
- Decision date
- 2023-06-16
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- Approval for resin changes for the CELLEX® Photopheresis Procedural Kit.
Current openFDA PMA Record#
- Device
- Therakos CELLEX Photopheresis Kit
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S103
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2023-06-16
- Decision code
- APPR
- Date received
- 2020-09-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for resin changes for the CELLEX® Photopheresis Procedural Kit.