PMA P860003S037

Device: UVAR XTS(TM) PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S037
Product code: LNR
Decision date: 2001-01-05
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR THE FOLLOWING SOFTWARE CHANGES: 1) REMOVAL OF SYSTEM ERROR F522:0000, 2) REMOVAL OF SYSTEM ERROR F581:0000, 3) CHANGE IN THE ALARM THRESHOLD FOR THE CENTRIFUGE BOWL VACUUM, AND 4) ADDITION OF NEW PRIMING STATE.

Current openFDA PMA Record#

Device: UVAR XTS(TM) PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S037
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2001-01-05
Decision code: APPR
Date received: 2000-07-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING SOFTWARE CHANGES: 1) REMOVAL OF SYSTEM ERROR F522:0000, 2) REMOVAL OF SYSTEM ERROR F581:0000, 3) CHANGE IN THE ALARM THRESHOLD FOR THE CENTRIFUGE BOWL VACUUM, AND 4) ADDITION OF NEW PRIMING STATE.