PMA P860003S092
- Device
- THERAKOS CELLEX Photopheresis Procedural Kit
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S092
- Product code
- LNR
- Decision date
- 2017-08-17
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- Approval for a design change to the pressure dome assembly.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX Photopheresis Procedural Kit
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S092
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2017-08-17
- Decision code
- APPR
- Date received
- 2017-06-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the pressure dome assembly.