PMA P860003S028
- Device
- UVAR PHOTOPHORESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S028
- Product code
- LNR
- Decision date
- 1997-03-25
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR THE USE OF EXTERNAL BIOLOGICAL INDICATORS TO MONITOR THE STERILIZATIN CYCLES FOR THE PHOTOPHERESIS TPS101 BLOOD TUBING SET, TPS102 PHOTOCEPTOR(R), AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL.
Current openFDA PMA Record#
- Device
- UVAR PHOTOPHORESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S028
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 1997-03-25
- Decision code
- APPR
- Date received
- 1997-01-30
- Approval order statement
- APPROVAL FOR THE USE OF EXTERNAL BIOLOGICAL INDICATORS TO MONITOR THE STERILIZATIN CYCLES FOR THE PHOTOPHERESIS TPS101 BLOOD TUBING SET, TPS102 PHOTOCEPTOR(R), AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL.