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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.
 
DeviceANGIO DYNAMICS 630PDT LASER
Generic NameSystem, laser, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP990021
Supplement NumberS002
Date Received05/26/2009
Decision Date10/13/2010
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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