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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
Classification Namesystem, laser, photodynamic therapy
Generic Nameblue light photodynamic therapy illuminator
ApplicantDUSA PHARMACEUTICALS, INC.
PMA NumberP990019
Supplement NumberS004
Date Received08/22/2006
Decision Date09/21/2006
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an alternate manufacturer for the timer assembly in the device.
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