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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 NameANGIO DYNAMICS 630PDT LASER
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser, surgical laser
ApplicantCONCORDIA LABORATORIES, INC
PMA NumberP990021
Supplement NumberS002
Date Received05/29/2009
Decision Date10/13/2010
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternative source of laser diode and modification of the thermal management of the device.
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