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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 Fiber Optic Diffuser
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS015
Date Received04/03/2018
Decision Date05/18/2018
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 of shelf life for the OPTIGUIDE Fiber Optic Diffuser, DCYL 700 Cylindrical Diffuser Series for four (4) years in all sizes of the DCYL 700 Series fibers (DCYL 710, 715, 720, 725, 750).
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