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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 NumberS007
Date Received06/27/2011
Decision Date07/07/2011
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a software change to eliminate the need to artificially limit the cycle lifetime for the blu-u treatment lamp system.
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