PMA P860003S062
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEMS
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S062
- Product code
- LNR
- Decision date
- 2011-10-28
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR A TECHNICAL BULLETIN THAT WILL BE SENT OUT TO USERS OF THE CELLEX¿ SYSTEM.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOPHERESIS SYSTEMS
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S062
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2011-10-28
- Decision code
- APPR
- Date received
- 2011-09-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A TECHNICAL BULLETIN THAT WILL BE SENT OUT TO USERS OF THE CELLEX¿ SYSTEM.