PMA P860003S057
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S057
- Product code
- LNR
- Decision date
- 2011-07-29
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S057
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2011-07-29
- Decision code
- APPR
- Date received
- 2011-01-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM.