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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received04/13/1994
Decision Date12/27/1995
Product Code MVG 
Docket Number 97M-0204
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR OPTIGUIDE FIBER OPTIC DIFFUSER, MODELS DCYL 10, DCYL 15, DCYL 25
Supplements:  S001 S002 S003 S007 S008 S010 S005 S004 S009 S006 S011 
S016 S015 S013 S014 S012 S017 
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