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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 THERAPHY ILLUMINATOR
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantSun Pharmaceutical Industries, Inc.
29 Dunham Road
Billerica, MA 01821
PMA NumberP990019
Supplement NumberS001
Date Received03/20/2000
Decision Date09/26/2000
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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