PMA P860003S064
- Device
- THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S064
- Product code
- LNR
- Decision date
- 2012-04-04
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO ENSURE THE APPROPRIATE DOSING OF HEPARIN FOR LOW BODY WEIGHT PATIENTS.
Current openFDA PMA Record#
- Device
- THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S064
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2012-04-04
- Decision code
- APPR
- Date received
- 2012-01-24
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO ENSURE THE APPROPRIATE DOSING OF HEPARIN FOR LOW BODY WEIGHT PATIENTS.