PMA P860003S065

Device: THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S065
Product code: LNR
Decision date: 2012-03-02
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A TECHNICAL BULLETIN (TECHNICAL BULLETIN XTS #1) THAT WILL BE SENT OUT TO USERS OF THE UVAR XTS PHOTOPHERESIS SYSTEM.

Current openFDA PMA Record#

Device: THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S065
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2012-03-02
Decision code: APPR
Date received: 2012-02-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A TECHNICAL BULLETIN (TECHNICAL BULLETIN XTS #1) THAT WILL BE SENT OUT TO USERS OF THE UVAR XTS PHOTOPHERESIS SYSTEM.