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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 NumberS030
Date Received04/29/1998
Decision Date09/07/1999
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to reflect the use of uvadex(r), the sterile liquid formulation of 8-methoxypsoralen (8-mop).