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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.
 
DevicePHOTOFRIN 630 PDT LASER
Generic NameSystem, laser, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP990021
Supplement NumberS003
Date Received10/06/2015
Decision Date06/28/2016
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the PHOTOFRIN 630 PDT Laser manufactured by Modulight, Inc located in Tampere, Finland.
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