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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(TM) CYLINDRICAL FIBER OPTIC
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Dr.
Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS005
Date Received08/21/1998
Decision Date11/23/1998
Product Code MVG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for commerical distributing of the modified DCYL Cylindrical Fiber Optics which incorporate a glued diffusing tip in place of the previously approved threaded tip. The device, as modified, will be marketed under the trade name OPTIGUIDE Cylindrical Fiber Optic (DCYL2 Diffuser Series and is indicated for: palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinon of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy, and treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
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