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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 NumberS006
Date Received12/10/2008
Decision Date01/09/2009
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of an updated model of the timer assembly used in the device.
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