PMA P860003S081
- Device
- THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S081
- Product code
- LNR
- Decision date
- 2015-11-02
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE ACCELEROMETER AND ASSOCIATED ACCELEROMETER ALARM FROM THE CELLEX® INSTRUMENT.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S081
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2015-11-02
- Decision code
- APPR
- Date received
- 2015-08-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE ACCELEROMETER AND ASSOCIATED ACCELEROMETER ALARM FROM THE CELLEX® INSTRUMENT.