PMA P860003S078
- Device
- THERAKOS CELLEXPHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S078
- Product code
- LNR
- Decision date
- 2015-03-19
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- MANUFACTURING PROCESS CHANGE FOR A COMPONENT OF THE THERAKOS CELLEX PHOTOPHERESIS SYSTEMS.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEXPHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S078
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2015-03-19
- Decision code
- OK30
- Date received
- 2015-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCESS CHANGE FOR A COMPONENT OF THE THERAKOS CELLEX PHOTOPHERESIS SYSTEMS.