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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, MODEL 4170
Generic NameSystem, laser, photodynamic therapy
ApplicantSun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica, MA 01821
PMA NumberP990019
Supplement NumberS003
Date Received03/03/2005
Decision Date10/06/2005
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF AN ALTERNATE MANUFACTURING SITE LOCATED AT DUSA PHARMACEUTICALS, INC., WILMINGTON, MASSACHUSETTS.
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