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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 Drive. Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS010
Date Received06/12/2002
Decision Date08/01/2003
Product Code MVG 
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
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