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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
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
DUSA PHARMACEUTICALS, INC.
25 upton dr.
wilmington, MA 01887
PMA NumberP990019
Supplement NumberS002
Date Received09/30/2002
Decision Date01/09/2003
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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