PMA P860003S074
- Device
- THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S074
- Product code
- LNR
- Decision date
- 2013-08-28
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR A CHANGE IN THE ADHESIVE USED FOR THE LIDSTOCK OF THE CELLEXS PROCEDURAL KIT PACKAGING.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S074
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2013-08-28
- Decision code
- APPR
- Date received
- 2013-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE ADHESIVE USED FOR THE LIDSTOCK OF THE CELLEXS PROCEDURAL KIT PACKAGING.