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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.
 
DeviceOPTIGUIDE Cylindrical Fiber Optic
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS017
Date Received11/02/2020
Decision Date02/24/2021
Product Code MVG 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the PB900 series to OPTIGUIDE® Cylindrical Diffuser fiber optics. The change being made (due to addition of the fiber that is equivalent to PB200 and PB700 fibers) is in two quality control procedures to accommodate the smaller diameter of this design.
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