PMA P860003S068
- Device
- THERAKOS CELLEX PHOTOPHRESES SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S068
- Product code
- LNR
- Decision date
- 2013-05-01
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM (SOFTWARE VERSION 4.1).
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOPHRESES SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S068
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2013-05-01
- Decision code
- APPR
- Date received
- 2012-11-06
- 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 (SOFTWARE VERSION 4.1).