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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDIOMED 630 PDT LASER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
CONCORDIA LABORATORIES, INC
5 canewood industrial park
st michael BB110
PMA NumberP990021
Date Received05/04/1999
Decision Date06/30/2000
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 00M-1387
Notice Date 07/14/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE DIOMED 630 PDT LASER, MODEL T2USA. THIS DEVICE IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN (PORFIMER SODIUM) AS A SOURCE OF ACTIVATION OF PHOTOFRIN FOR: A) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY. B) REDUCTION OF OBSTRUCTING AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLET
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 
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