PMA P860003S053
- Device
- THERAKOS CELLEX* PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S053
- Product code
- LNR
- Decision date
- 2009-05-27
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- CHANGE TO PERFORM FINAL PRODUCT TESTING ON CELLEX PROCEDURAL KITS AT A CONTRACT MANUFACTURER.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX* PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S053
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2009-05-27
- Decision code
- OK30
- Date received
- 2009-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO PERFORM FINAL PRODUCT TESTING ON CELLEX PROCEDURAL KITS AT A CONTRACT MANUFACTURER.