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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
Generic NameSystem, laser, photodynamic therapy
ApplicantSun Pharmaceutical Industries, Inc.
29 Dunham Rd.
Billerica, MA 01821
PMA NumberP990019
Supplement NumberS002
Date Received09/30/2002
Decision Date01/09/2003
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXTENSION OF THE CALIBRATION INTERVAL FROM THE CURRENTLY APPROVED 500 CYCLES (WITH A 50 CYCLE BUFFER) TO 1600 CYCLES (WITH A 50 CYCLE BUFFER).
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