PMA P860003S071
- Device
- THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S071
- Product code
- LNR
- Decision date
- 2013-08-08
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR CHANGES IN TWO MATERIALS USED IN MOLDING COMPONENTS OF THE UVAR® XTS® AND CELLEX® PROCEDURAL KITS.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S071
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2013-08-08
- Decision code
- APPR
- Date received
- 2013-02-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES IN TWO MATERIALS USED IN MOLDING COMPONENTS OF THE UVAR® XTS® AND CELLEX® PROCEDURAL KITS.