PMA P860003S040

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S040
Product code: LNR
Decision date: 2002-04-12
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A LABELING CHANGE (INCLUSION OF AN ADDITIONAL WARNING) TO ADDRESS THE POTENTIAL FOR THE DEVELOPMENT OF HYPOVOLEMIA AND HYPOTENSION DURING PHOTOPHERESIS TREATMENTS IN PATIENTS WITH ELEVATED TRIGLYCERIDE LEVELS (HYPERLIPIDEMIA), SUCH AS PATIENTS RECEIVING CERTAIN CUTANEOUS T-CELL LYMPHOMA DRUGS, LIKE TARGRETIN. (BEXAROTENE).

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S040
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2002-04-12
Decision code: APPR
Date received: 2002-03-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE (INCLUSION OF AN ADDITIONAL WARNING) TO ADDRESS THE POTENTIAL FOR THE DEVELOPMENT OF HYPOVOLEMIA AND HYPOTENSION DURING PHOTOPHERESIS TREATMENTS IN PATIENTS WITH ELEVATED TRIGLYCERIDE LEVELS (HYPERLIPIDEMIA), SUCH AS PATIENTS RECEIVING CERTAIN CUTANEOUS T-CELL LYMPHOMA DRUGS, LIKE TARGRETIN. (BEXAROTENE).