Premarket Approval (PMA)

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
• Applicant: THERAKOS, INC.
• PMA Number: P860003
• Supplement Number: S062
• Date Received: 09/29/2011
• Decision Date: 10/28/2011
• Product Code: LNR [ Registered Establishments with LNR ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval for a technical bulletin that will be sent out to users of the cellex¿ system.