FDA.reportPublic FDA data

PMA P860003S100

Device
Therakos CELLEX Procedural Kit
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S100
Product code
LNR
Decision date
2019-01-10
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
Change in the manufacturing process for the CELLEX Procedural Kits' drive tube assemblies so that the same manufacturing steps used at the approved Mack Molding manufacturing site can also be used at the approved Harmac Medical, Buffalo, New York site.

Current openFDA PMA Record#

Device
Therakos CELLEX Procedural Kit
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S100
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2019-01-10
Decision code
OK30
Date received
2018-12-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the manufacturing process for the CELLEX Procedural Kits' drive tube assemblies so that the same manufacturing steps used at the approved Mack Molding manufacturing site can also be used at the approved Harmac Medical, Buffalo, New York site.