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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 NumberS004
Date Received08/02/2017
Decision Date01/17/2018
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 the PHOTOFRIN 630 PDT Laser to be manufactured by UnionMed Tech, Inc. Bridgewater, New Jersey.
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