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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 NumberS003
Date Received03/03/2005
Decision Date10/06/2005
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 No
Approval Order Statement 
Approval of an alternate manufacturing site located at dusa pharmaceuticals, inc. , wilmington, massachusetts.
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