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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
Generic NameSystem, laser, photodynamic therapy
ApplicantSun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica, MA 01821
PMA NumberP990019
Supplement NumberS007
Date Received06/27/2011
Decision Date07/07/2011
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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