PMA P860003S088
- Device
- Therakos CELLEX and UVAR XTS Procedural Kits
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S088
- Product code
- LNR
- Decision date
- 2017-05-02
- Classification
- System, Photopheresis, Extracorporeal
- Generic name
- System, photopheresis, extracorporeal
- Approval order statement
- Replace the ultrasonic welder and qualify new mold tools used for cuvette assemblies.
Current openFDA PMA Record#
- Device
- Therakos CELLEX and UVAR XTS Procedural Kits
- Applicant
- Therakos Development Limited
- PMA number
- P860003
- Supplement
- S088
- Product code
- LNR
- Generic name
- System, photopheresis, extracorporeal
- Decision date
- 2017-05-02
- Decision code
- OK30
- Date received
- 2017-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the ultrasonic welder and qualify new mold tools used for cuvette assemblies.