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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) FIBER OPTIC DIFFUSER
Generic NameSYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Drive. Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS004
Date Received03/24/1998
Decision Date12/23/1998
Product Code MVG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).
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