FDA.reportPublic FDA data

PMA P860003S099

Device
Therakos CELLEX Procedural Kit
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S099
Product code
LNR
Decision date
2018-11-01
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
Change in the device's manufacturing validation implementing the use of an automated inspection fixture that will inspect the integrity of 100% of all THERAKOS® CELLEX® Procedural Kit Centrifuge Outer Bowl welds.

Current openFDA PMA Record#

Device
Therakos CELLEX Procedural Kit
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S099
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2018-11-01
Decision code
OK30
Date received
2018-10-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the device's manufacturing validation implementing the use of an automated inspection fixture that will inspect the integrity of 100% of all THERAKOS® CELLEX® Procedural Kit Centrifuge Outer Bowl welds.