PMA P860003S041

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S041
Product code: LNR
Decision date: 2002-11-25
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MACK MOLDING COMPANY, ARLINGTON, VERMONT. THE FACILITY WILL MANUFACTURE THE XTS INSTRUMENT AND XT20 LIGHT ASSEMBLY.

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S041
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2002-11-25
Decision code: APPR
Date received: 2002-04-01
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MACK MOLDING COMPANY, ARLINGTON, VERMONT. THE FACILITY WILL MANUFACTURE THE XTS INSTRUMENT AND XT20 LIGHT ASSEMBLY.