PMA P860003S066

Device: THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S066
Product code: LNR
Decision date: 2012-11-09
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR THE ADDITION OF 8 RIBS TO THE NECK OF THE CENTRIFUGE BOWLS USED IN THE DEVICE AND FOR THE ACCOMPANYING PACKAGING CHANGES.

Current openFDA PMA Record#

Device: THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S066
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2012-11-09
Decision code: APPR
Date received: 2012-09-10
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF 8 RIBS TO THE NECK OF THE CENTRIFUGE BOWLS USED IN THE DEVICE AND FOR THE ACCOMPANYING PACKAGING CHANGES.