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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.
 
Trade NameBLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170
Classification Namesystem, laser, photodynamic therapy
Generic Nameblue light photodynamic therapy illuminator
ApplicantDUSA PHARMACEUTICALS, INC.
PMA NumberP990019
Supplement NumberS005
Date Received10/30/2007
Decision Date10/10/2008
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the national biological corp. , beachwood, ohio facility, for contract manufacturing.
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