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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 (DCYL Cylindrical Diffuser Series)
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS012
Date Received10/24/2017
Decision Date01/17/2018
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 for replacement resin for the manufacturing of "heat shrink" tubing used in all sizes of the DCYL 200 Series fibers (DCYL 210, 215,220,225, 250).
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