|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||UVAR PHOTOPHORESIS SYSTEM|
|Classification Name||system, photopheresis, extracorporeal|
|Generic Name||extracorporeal photopheresis system|
|Applicant||THERAKOS, INC., JOHNSON & JOHNSON|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of external biological indicators to monitor the sterilizatin cycles for the photopheresis tps101 blood tubing set, tps102 photoceptor(r), and a commercially available blood centrifuge bowl.