|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS|
|Classification Name||system, photopheresis, extracorporeal|
|Generic Name||extracorporeal photopheresis system|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to ensure the appropriate dosing of heparin for low body weight patients.