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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 NumberS005
Date Received04/27/2021
Decision Date03/02/2022
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PI (an updated design of the currently marketed laser, the DIOMED 630 PDT Laser, Model T2USA), and B&W TEK Inc., located at 18 Shea Way, Suite 103, Newark, DE, 19713 as the new manufacturing site of the PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PIN.
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