PMA P860003S051
- Device
- UVAR XTS PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S051
- Product code
- LNR
- Decision date
- 2009-01-16
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- TRANSFER OF THREE (3) UVAR XTS PHOTOPHERESIS PROCEDURAL KIT FINISHED PRODUCT QUALITY CONTROL TEST TO A CONTRACT TESTING LABORATORY.
Current openFDA PMA Record#
- Device
- UVAR XTS PHOTOPHERESIS SYSTEM
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S051
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2009-01-16
- Decision code
- OK30
- Date received
- 2008-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TRANSFER OF THREE (3) UVAR XTS PHOTOPHERESIS PROCEDURAL KIT FINISHED PRODUCT QUALITY CONTROL TEST TO A CONTRACT TESTING LABORATORY.