PMA P860003S029

Device: UVAR PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S029
Product code: LNR
Decision date: 1998-02-26
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for Griffith Micro Science in Glens Falls, New York, to serve as the contract sterilization facility for th esterilization of the TK001 Photopheresis Procedural Kit, which is validated utilizing a biological indicator system internal to the product.

Current openFDA PMA Record#

Device: UVAR PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S029
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 1998-02-26
Decision code: APPR
Date received: 1997-09-11
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for Griffith Micro Science in Glens Falls, New York, to serve as the contract sterilization facility for th esterilization of the TK001 Photopheresis Procedural Kit, which is validated utilizing a biological indicator system internal to the product.