PMA P860003S027

Device: UVAR PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S027
Product code: LNR
Decision date: 1996-05-17
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL TO CHANGE THE MANUFACTURING FACILITY FOR THE TPS102 PHOTOCEPTOR COMPONENT OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS AT 2201 BAILEY AVENUE IN BUFFALO, NEW YORK (ESTABLISHMENT REGISTRATION #1317547)

Current openFDA PMA Record#

Device: UVAR PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S027
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 1996-05-17
Decision code: APPR
Date received: 1995-10-05
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO CHANGE THE MANUFACTURING FACILITY FOR THE TPS102 PHOTOCEPTOR COMPONENT OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS AT 2201 BAILEY AVENUE IN BUFFALO, NEW YORK (ESTABLISHMENT REGISTRATION #1317547)