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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 Nameextracorporeal photopheresis system
PMA NumberP860003
Supplement NumberS029
Date Received09/11/1997
Decision Date02/26/1998
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for griffith micro science in glens falls, new york, to serve as the contract sterilization facility for th esterilization of the tk001 photopheresis procedural kit, which is validated utilizing a biological indicator system internal to the product.