PMA P860003S032

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S032
Product code: LNR
Decision date: 1998-09-01
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton.

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S032
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 1998-09-01
Decision code: APPR
Date received: 1998-08-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton.