- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM, INSTRUMENT, LIGHT ASSEMBLY, PROCEDURAL KIT.
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S087
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2017-04-27
- Decision code
- APPR
- Date received
- 2016-05-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the software, circuit board, drive tube bearing retainer, power supply, and labeling.