PMA P860003S075
- Device
- THERAKOS CELLEX PHOTOPHERESIS KIT
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S075
- Product code
- LNR
- Decision date
- 2014-05-09
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR A CHANGE IN THE GEOMETRY OF THE STAND-OFFS FEATURED ON THE INNER LOWER BOWL COVER OF THE CELLEX® PROCEDURAL KIT¿S CENTRIFUGE BOWL
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOPHERESIS KIT
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S075
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2014-05-09
- Decision code
- APPR
- Date received
- 2014-02-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE GEOMETRY OF THE STAND-OFFS FEATURED ON THE INNER LOWER BOWL COVER OF THE CELLEX® PROCEDURAL KIT¿S CENTRIFUGE BOWL