PMA P860003S095

Device: CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S095
Product code: LNR
Decision date: 2017-09-14
Generic name: System, photopheresis, extracorporeal
Approval order statement: Manufacturing site change for the pressure dome assembly component of the Therakos CELLEX Photopheresis Procedural Kit used in the Therakos CELLEX Photopheresis System.

Current openFDA PMA Record#

Device: CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S095
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2017-09-14
Decision code: OK30
Date received: 2017-08-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing site change for the pressure dome assembly component of the Therakos CELLEX Photopheresis Procedural Kit used in the Therakos CELLEX Photopheresis System.