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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 (pb 200, PB 700 Series)
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS016
Date Received12/19/2018
Decision Date05/09/2019
Product Code MVG 
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 design update for the OPTIGUIDE Diffusing Fiber Optics for the new series identified as the PB200 and PB700 Series of OPTIGUIDE Diffusing Fiber Optics and for the approval of a new manufacturing site. The new manufacturing site is Laser Peripherals LLC, 13355 10th Avenue, North Suite #110, Plymouth, Minnesota.
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