PMA P860003S055
- Device
- UVAR XTS PROCEDURAL KIT
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S055
- Product code
- LNR
- Decision date
- 2011-01-25
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- APPROVAL FOR USE OF A NEW WELDER IN MANUFACTURING THE CENTRIFUGE BOWL.
Current openFDA PMA Record#
- Device
- UVAR XTS PROCEDURAL KIT
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S055
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2011-01-25
- Decision code
- APPR
- Date received
- 2010-09-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR USE OF A NEW WELDER IN MANUFACTURING THE CENTRIFUGE BOWL.