PMA P860003S035

Device: UVAR XTS PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S035
Product code: LNR
Decision date: 2000-01-14
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval is for a new material, Codan Polypropylene RE764F/Cawiton, to be used in the body of the drip chamber of the UVAR XTS System's disposable set.

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S035
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2000-01-14
Decision code: APPR
Date received: 1999-12-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval is for a new material, Codan Polypropylene RE764F/Cawiton, to be used in the body of the drip chamber of the UVAR XTS System's disposable set.