PMA P860003S101
- Device
- Therakos CELLEX Procedural Kit
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S101
- Product code
- LNR
- Decision date
- 2019-05-13
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- Approval for design changes to the pump tubing organizer assembly of the Therakos CELLEX Procedural Kit.
Current openFDA PMA Record#
- Device
- Therakos CELLEX Procedural Kit
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S101
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2019-05-13
- Decision code
- APPR
- Date received
- 2019-02-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the pump tubing organizer assembly of the Therakos CELLEX Procedural Kit.