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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDIOMED 630 PDT LASER
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser, surgical laser
ApplicantDIO-MED CORP.
PMA NumberP990021
Supplement NumberS001
Date Received06/12/2002
Decision Date08/01/2003
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use with the photosensitive drug photofrin for the additional indication for use for the ablation of high-grade dysplasia in barrett's esophagus patients who do not undergo esophagectomy.
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