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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 THERAPHY ILLUMINATOR
Classification Namesystem, laser, photodynamic therapy
ApplicantDUSA PHARMACEUTICALS, INC.
PMA NumberP990019
Supplement NumberS001
Date Received03/20/2000
Decision Date09/26/2000
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modified version of the blu-u(tm) blue light photodynamic therapy illuminator. The device, as modified, will be marketed under the trade name blu-u(tm) model 4170.
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