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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namesystem, photopheresis, extracorporeal
Generic Namesystem, photopheresis, extracorporeal
440 route 22 east
suite 140
bridgewater, NJ 08807
PMA NumberP860003
Supplement NumberS031
Date Received08/05/1998
Decision Date08/10/1999
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software. The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy.