PMA P860003S049
- Device
- THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S049
- Product code
- LNR
- Decision date
- 2008-08-29
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR A MATERIAL CHANGE FOR THE GASKET USED IN THE CENTRIFUGE BOWL COVER OF THE UVAR XTS PHOTOPHERESIS SYSTEM.
Current openFDA PMA Record#
- Device
- THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S049
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2008-08-29
- Decision code
- APPR
- Date received
- 2008-06-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MATERIAL CHANGE FOR THE GASKET USED IN THE CENTRIFUGE BOWL COVER OF THE UVAR XTS PHOTOPHERESIS SYSTEM.