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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.
 
DeviceBLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
DUSA PHARMACEUTICALS, INC.
25 upton dr.
wilmington, MA 01887
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/material
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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