PMA P860003S054
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S054
- Product code
- LNR
- Decision date
- 2009-09-15
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR THE TRANSFER OF FINISHED PRODUCT TESTING TO STERIPRO LABS FROM THERAKOS, INC.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S054
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2009-09-15
- Decision code
- APPR
- Date received
- 2009-06-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE TRANSFER OF FINISHED PRODUCT TESTING TO STERIPRO LABS FROM THERAKOS, INC.